Biopsy Devices and Related Methods

ABSTRACT

Apparatus and methods provided to remove biopsy specimens from bone and/or associated bone marrow. A powered driver may rotate a biopsy needle at an optimum speed to obtain the biopsy specimen. A thread or a groove may be disposed on interior portions of the biopsy needle. The thread or groove may engage a biopsy specimen and enhance removal of a bone marrow core from cancellous bone. Manufacturing procedures are provided for bonding a single helical thread with interior portions of the biopsy needle. The apparatus may also include a biopsy sample ejector and/or ejector funnel. A biopsy needle set may include a cannula and a trocar with respective tips having optimum configurations, dimensions and/or orientations relative to each other to optimize penetration of a bone and/or bone marrow with minimum patient trauma and enhanced reliability of obtaining a biopsy specimen.

RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/825,325 entitled “Apparatus and Methods forBiopsy and Aspiration of Bone Marrow” filed Sep. 12, 2006. The contentsof this application is incorporated herein in it's entirety by thisreference.

This Application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/910,122 entitled “Powered Driver IntraosseousDevice and Methods To Access Bone Marrow” filed Apr. 4, 2007. Thecontents of this application is incorporated herein in it's entirety bythis reference.

TECHNICAL FIELD

The present disclosure is related generally to medical procedures suchas aspiration and biopsy of bone marrow along with apparatus and methodsassociated with powered drivers, coupler assemblies, aspiration needles,biopsy needles, and associated medical procedure trays and kits.

BACKGROUND OF THE DISCLOSURE

There are many clinical conditions where it is important to access andretrieve bone marrow. In some cases it may be necessary to treatdiseases with bone marrow or stem cell transplants to restorefunctioning blood cells. Such conditions may include, but are notlimited to, acute leukemia, brain tumors, breast cancer, Hodgkin'sdisease, multiple myeloma, neuroblastoma, non-Hodgkin's lymphomas,ovarian cancer, sarcoma and testicular cancer. In other cases it isnecessary to access bone marrow to obtain a sample or specimen of themarrow for diagnostic testing. These conditions may include, but are notlimited to, cancers of any type and hematologic disease of any origin.

Gaining access to bone and associated bone marrow for a small biopsyspecimen or aspiration of a larger quantity of bone marrow may bedifficult, traumatic and occasionally dangerous, depending on eachselected target area for harvesting bone and/or associated bone marrow,operator expertise and patient anatomy. Currently available devices andtechniques for gaining access to a bone and associated bone marrow mayinclude an intraosseous (IO) needle with a removable trocar disposedtherein. Various shapes and sizes of handles may be used to apply manualpressure and to manually rotate the IO needle and removable trocar as aset. Such manual IO devices often require substantial force to breakthrough the outer cortex of a bone. Exertion of such force may causepain to a patient and may sometimes damage the bone and/or IO device.Such force may cause damage when harvesting bone marrow from childrenwith softer bone structures or any patient with bones deteriorated bydisease (cancer).

Occasionally a core specimen of bone and/or bone marrow may not besuccessfully retrieved using a standard biopsy needle. Thus, multipleinsertions at different sites may be necessary to obtain a satisfactorybone and/or bone marrow biopsy specimen. Risks to health care personnelmay be higher because of increased handling of blood contaminated sharpinstruments. Accidental needle sticks and missed target areas mayfurther complicate procedures and increase risks to health carepersonnel and/or patients.

Conventional bone marrow transplant techniques may require multiplepenetration sites (up to 20 per patient) in order to obtain enough bonemarrow to perform a routine bone marrow transplant. This procedure isoften labor intensive. Conventional biopsy needles and/or aspirationneedles are typically inserted with considerable manual force. Thisforce may cause loss of control or operator fatigue. When the biopsyneedle or aspiration needle is in place, an associated trocar isgenerally removed and a syringe attached to one end of the needle toaspirate a few cubic centimeters of bone marrow. The biopsy oraspiration needle is then withdrawn. A new insertion site may bepenetrated, often about a centimeter from the first insertion site. Theprocedure may be repeated multiple times.

SUMMARY OF THE DISCLOSURE

In accordance with teachings of the present disclosure, apparatus andmethods are provided for aspiration and/or biopsy of bone marrow. Suchapparatus and methods may also be used during various types of stem celltransplant procedures. Various teaching of the present disclosure may beused with other types of intraosseous devices and other types of medicalprocedures outside the field of providing vascular access for treatmentof a patient. Examples of such procedures may include, but are notlimited to, kyphoplasty, vertebral plasty, placement of wires and screwsassociated with replacement of joints and internal fixation of bonefractures and many other orthopedic procedures. Teachings of the presentdisclosure may also be incorporated into variousgastroenterology-urology biopsy devices and procedures.

One aspect of the present disclosure may include a bone marrowaspiration system having an aspiration needle set along with a powereddriver and coupler assembly operable to insert the aspiration needle setinto a bone and associated bone marrow. The aspiration needle set mayinclude a cannula having a single lumen and a trocar or stylet operableto be slidably disposed within the lumen of the cannula. Various typesof connections including, but not limited to, Luer lock connections maybe used to releasably engage the trocar within the cannula.

Another aspect of the present disclosure may include a bone and/or bonemarrow biopsy system having a biopsy needle or biopsy needle set alongwith a powered driver or a manual driver. The powered driver and acoupler assembly may be used to insert the biopsy needle or biopsyneedle set into a bone and associated bone marrow. The biopsy needle setmay include a cannula having a single lumen and a trocar operable to beslidably or releasably disposed within the lumen of the cannula. Suchneedles and needle sets may be used in connection with detection and/ortreatment of various cancers and other disease indications.

Still another aspect of the present disclosure may include accessingbone marrow by inserting an intraosseous needle or needle set into abone and associated bone marrow using a powered driver and couplerassembly operable to rotate the intraosseous needle or needle set at anoptimum speed to obtain a biopsy specimen of the bone and/or associatedbone marrow. A single helical thread may be provided in one end of abiopsy needle to enhance capture of a biopsy specimen by screwing thesingle helical thread into associate cancellous bone to capture a bonemarrow specimen or bone marrow core.

One aspect of the present disclosure may include placing a powereddriver within a containment bag or sterile enclosure to provideisolation between the powered driver and an exterior environment. Thecontainment bag may be formed from relatively flexible, lightweight,clear plastic-type materials. The containment bag may include a portassembly operable to be releasably engaged with one end of the powereddriver and to maintain a fluid barrier with adjacent portions of adriver housing. An intraosseous device may be attached to one end of theport assembly. A drive shaft extending from the powered driver may bereleasably engage with another end of the port assembly.

A further aspect of the present disclosure may include a biopsy kithaving a biopsy needle and an ejector or ejector rod operable to removea bone and/or bone marrow specimen from a biopsy needle. A funnel(sometimes referred to as an “ejector funnel”) may also be includedwithin the biopsy kit. The funnel may accommodate insertion of theejector into one end of the biopsy needle. The funnel may include areduced inside diameter portion formed in accordance with teachings ofthe present disclosure. For some embodiments, interior portions of thefunnel may function as a “one way connector” which may allow the funnelto function as a sharps protector for one end of the biopsy needledisposed therein.

A further aspect of the present disclosure may include a couplerassembly operable to releasably engage an intraosseous device withportions of a drive shaft extending from one end of a powered driver.The coupler assembly may allow the powered driver to insert theintraosseous device at an insertion site (power in.) The couplerassembly may also allow the powered driver to “spin” the intraosseousdevice during removal from the insertion site (power out). This featureof the present disclosure may also be referred to as “power in and powerout.”

Apparatus and methods incorporating teachings of the present disclosuremay:

Reduced physical requirements to insert an IO device into bone andassociated bone marrow.

Better control of an IO device during insertion.

Increased speed to complete an IO procedure.

Reduced discomfort to patients.

Simple, intuitive systems and procedures for an operator.

This summary contains only a limited number of examples of variousembodiments and features of the present disclosure. Additional examplesof embodiments and features will be discussed in the DetailedDescription of the Disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of the present embodimentsand advantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A is a schematic drawing showing an isometric view of one exampleof a aspiration needle set incorporating teachings of the presentdisclosure disposed in a kit;

FIG. 1B is a schematic drawing showing an isometric view of one exampleof a biopsy needle set incorporating teachings of the present disclosuredisposed in a kit;

FIG. 1C is a schematic drawing showing an isometric view of one exampleof a medical procedure tray including a biopsy needle set and othercomponents satisfactory for use with a powered driver in a sterileenvironment in accordance with teachings of the present disclosure;

FIG. 1D is a drawing in section taken along lines 1D-1D of FIG. 1C;

FIG. 1E is a schematic drawing showing an isometric view of the medicalprocedure tray of FIG. 1D with a non-sterile medical device disposed ina containment bag in accordance with teachings of the presentdisclosure;

FIG. 1F is a schematic drawing showing still another isometric view ofthe medical procedure tray of FIG. 1D with the non-sterile medicaldevice disposed in the containment bag in accordance with teachings ofthe present disclosure;

FIG. 1G is a schematic drawing showing a further isometric view of themedical procedure tray of FIG. 1C;

FIG. 1H is a schematic drawing showing an isometric view of the medicalprocedure tray of FIG. 1G after unfolding a first drape and a seconddrape;

FIG. 1I is a schematic drawing showing an isometric view of the medicalprocedure tray of FIG. 1G after a powered driver has been engaged with acoupler assembly in accordance with teachings of the present disclosure;

FIG. 1J is a schematic showing an isometric view of the medicalprocedure tray of FIG. 1G after lifting the second drape to enclose thepowered driver (one example of a non-sterile medical device) in thecontainment bag;

FIG. 2 is a schematic drawing showing one example of a powered driveroperable for use with intraosseous (IO) devices incorporating teachingsof the present disclosure;

FIG. 3A is a schematic drawing showing an isometric view of theaspiration needle of FIG. 1A;

FIG. 3B is a schematic drawing showing an exploded view of theaspiration needle set of FIG. 3A;

FIG. 3C is a schematic drawing showing an exploded, isometric view ofone example of a biopsy needle incorporating teachings of the presentdisclosure;

FIG. 3D is a schematic drawing showing an isometric view of anotherexample of an intraosseous needle set incorporating teachings of thepresent disclosure;

FIG. 3E is a schematic drawing showing an isometric view with portionsbroken away of the tips of the intraosseous needle set of FIG. 3A;

FIG. 3F is a schematic drawing showing an isometric view of oneembodiment of the tip of an intraosseous device or cannula incorporatingteachings of the present disclosure;

FIG. 3G is a schematic drawing showing an isometric view of anotherembodiment of the tip of a biopsy needle incorporating teachings of thepresent disclosure;

FIG. 3H is a schematic drawing showing an isometric view of stillanother embodiment of the tip of an intraosseous device or catheterincorporating teachings of the present disclosure;

FIG. 3I is a schematic drawing showing an isometric view with portionsbroken away of a intraosseous needle set incorporating teachings of thepresent disclosure;

FIG. 3J is a schematic drawing showing an isometric view with portionsbroken away of another example of a biopsy needle set incorporatingteachings of the present disclosure;

FIG. 4A is a schematic drawing partially in section and partially inelevation with portions broken away showing an exploded isometric viewof a mandrel operable to install a thread insert within portions of abiopsy needle in accordance with teachings of the present disclosure;

FIG. 4B is a schematic drawing showing one example of a thread insertwhich may be disposed within the longitudinal bore of a biopsy needle inaccordance with teachings of the present disclosure;

FIG. 4C is a schematic drawing in section with portions broken awayshowing one example of a biopsy needle with a single helical threaddisposed within one end of the biopsy needle incorporating teachings ofthe present disclosure;

FIG. 4D is a schematic drawing in section with portions broken awayshowing another example of a biopsy needle with a single helical threaddisposed within one end of the biopsy needle in accordance withteachings of the present disclosure;

FIG. 4E is a schematic drawing in section and in elevation with portionsbroken away showing a biopsy needle set including a trocar and a singlehelical thread disposed proximate one end of a generally hollow cannulain accordance with teachings of the present disclosure;

FIG. 5A is a schematic drawing showing an exploded, isometric view of apowered driver, coupler assembly and an intraosseous deviceincorporating teachings of the present disclosure;

FIG. 5B is a schematic drawing showing another exploded, isometric viewof the coupler assembly and intraosseous device of FIG. 5A;

FIG. 5C is a schematic drawing in section with portions broken awayshowing another exploded view of the powered driver, coupler assemblyand intraosseous device of FIG. 5A;

FIG. 5D is schematic drawing showing an end view of the coupler assemblytaken along lines 5D-5D of FIG. 5C prior to insert one end of a deviceshaft therein;

FIG. 5E is a schematic drawing in section with portions broken awayshowing the powered driver, coupler assembly and intraosseous device ofFIG. 5A;

FIG. 5F is a schematic drawing in section with portions broken awayshowing the coupler assembly of FIG. 5D in a second position allowingrelease of a powered driver from a receptacle disposed in the first endof the coupler assembly;

FIG. 5G is a schematic drawing in section showing various features of acoupler assembly and latch mechanism incorporating teachings of thepresent disclosure taken along lines 5G-5G of FIG. 5E;

FIG. 5H is a schematic drawing in section showing various features of acoupler assembly and latch mechanism incorporating teachings of thepresent disclosure taken along lines 5H-5H of FIG. 5F;

FIG. 5I is a schematic drawing in section with portions broken awayshowing another example of a coupler assembly incorporating teachings ofthe present disclosure;

FIG. 6A is a schematic drawing showing an alternative embodiment of acoupler assembly operable to releasably engage an intraosseous devicewith one end of a drive shaft extending from a powered driver inaccordance with teachings of the present disclosure;

FIG. 6B is a schematic drawing in section with portions broken awayshowing portions of the powered driver, coupler assembly andintraosseous device of FIG. 6A;

FIG. 7A is a schematic drawing showing an isometric view with portionsbroken away of a powered driver, containment bag or sterile sleeve andcoupler assembly incorporating teachings of the present disclosure;

FIG. 7B is a schematic drawing showing another view of the powereddriver disposed in the containment bag of FIG. 7A in accordance withteachings of the present disclosure;

FIG. 8 is a schematic drawing showing an exploded isometric view of anintraosseous device and a coupler assembly incorporating teachings ofthe present disclosure which may be satisfactorily used with a powereddriver in accordance with teachings of the present disclosure or amanual driver;

FIG. 9A is a schematic drawing showing an exploded, isometric view of abiopsy specimen ejector and associated funnel incorporating teachings ofthe present disclosure;

FIG. 9B is a schematic drawing showing an isometric view of anotherexample of a biopsy specimen ejector and associated funnel incorporatingteachings of the present disclosure;

FIG. 9C is a schematic drawing in section of the funnel of FIG. 9B; and

FIG. 10 is a schematic drawing in section and in elevation with portionsbroken away showing an aspiration needle disposed at a target site andcommunicating with a bone marrow aspiration system in accordance withteachings of the present disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Preferred embodiments of the disclosure and various advantages may beunderstood by reference to FIGS. 1A-10, wherein like numbers refer tosame and like parts.

The term “containment bag” as used in this application may include anysterile sleeve, sterile envelope, sterile glove, sterile enclosure orany other device incorporating teachings of the present disclosure andoperable to allow engaging a non-sterile device with a sterile deviceand conducting a medical procedure requiring a sterile field or sterileenvironment.

For some applications a non-sterile powered driver may be placed in acontainment bag incorporating teachings of the present disclosure andengaged with a sterile intraosseous device for use during variousmedical procedures requiring a sterile field or sterile environment.Such containment bags may be attached to a coupler assembly or any otherdevice incorporating teachings of the present disclosure to prevent thenon-sterile powered driver from contaminating the sterile intraosseous(IO) device during and after engagement of the non-sterile powereddriver with the IO device.

The term “driver” as used in this application may include any type ofpowered driver satisfactory for inserting an intraosseous (IO) deviceinto a selected portion of a patient's vascular system. Such powereddrivers often rotate a drive shaft extending therefrom. However, variousteachings of the present disclosure may be used with powered driversthat reciprocate an associated drive shaft (not expressly shown).

Various techniques may be satisfactorily used to releasably engage orattach an IO device with a powered driver in accordance with teachingsof the present disclosure. For example a wide variety of couplerassemblies, port assemblies, connectors, receptacles, fittings, hubs,hub assemblies, latching mechanisms and/or other types of connectingdevices incorporating teachings of the present disclosure may besatisfactorily used to releasably engage an IO device with a powereddriver.

Various types of coupler assemblies incorporating teachings of thepresent disclosure may be satisfactorily used to releasably engage oneend of a shaft extending from a driver with one end of an intraosseousdevice. For some embodiments the powered driver may include a driveshaft having one end with a generally hexagonal cross section operableto be releasably engaged with a latch mechanism disposed in one end of acoupler assembly. For some embodiments a coupler assembly incorporatingteachings of the present disclosure may be referred to as a “hands free”coupler, a quick disconnect or quick release coupler and/or portassembly.

Respective latch mechanisms may be disposed proximate a first end and asecond end of a coupler assembly in accordance with teachings of thepresent disclosure. Pushing one end of a drive shaft extending from apowered driver into the second end of the coupler assembly may result inan annular recess disposed in the one end of the drive shaft “snapping”into releasable engagement with the respective latch mechanism. Pushingone end of an intraosseous device into the first end of the couplerassembly may result in an annular recess in the one end of theintraosseous device “snapping” into releasable engagement with therespective latch mechanism.

For some embodiments, a coupler assembly or port assembly may be engagedwith a containment bag or sterile sleeve in accordance with teachings ofthe present disclosure. Coupler assemblies and/or hub assembliesincorporating teachings of the present disclosure allow easy separationof an associated powered driver from an IO device such that the IOdevice may remain in place in a patient to allow bone marrow aspirationor removal of bone and/or bone marrow biopsy specimens. Such couplerassemblies and/or port assemblies may also allow an associated powereddriver to “spin” or rotate an attached IO device while withdrawing an IOdevice from an insertion site or changing the depth of penetration of anIO device in a target area. Rotating the IO device during withdrawal orchanging depth (power out) may substantially improve patient comfort andreduce potential trauma to bone and soft body tissue proximate aninsertion site.

A powered driver may be used to insert an IO device incorporatingteachings of the present disclosure into a selected target area ortarget site in ten seconds or less. However, various teachings of thepresent disclosure are not limited to use with powered drivers. Manualdrivers and spring powered drivers may also be used with IO devicesincorporating teachings of the present disclosure.

Examples of manual drivers are shown in copending patent applicationSer. No. 11/042,912 entitled Manual Intraosseous Device filed Jan. 25,2005(now U.S. patent Ser. No. ______) (073252.0125).

The term “fluid” may be used in this application to include liquids suchas, but not limited to, blood, water, saline solutions, IV solutions,plasma or any mixture of liquids, particulate matter, dissolvedmedication and/or drugs associated with biopsy or aspiration of bonemarrow or communication of fluids with bone marrow or other targetsites. The term “fluid” may also be used in this patent application toinclude any body fluids and/or liquids containing particulate mattersuch as bone marrow and/or cells which may be withdrawn from a targetarea.

The terms “harvest” and “harvesting” may be used in this application toinclude bone and/or bone marrow biopsy and bone marrow aspiration. Boneand/or bone marrow biopsy (sometimes referred to as “needle biopsy”) maybe generally described as removing a relatively small piece or specimenof bone and/or bone marrow from a selected target area for biopsypurposes. Bone marrow aspiration (sometimes referred to as “bone marrowsampling”) may be generally described as removing larger quantities ofbone marrow from a selected target area. Relatively large quantities ofbone marrow may be used for diagnostic, transplantation and/or researchpurposes. For example some stem cell research techniques may requirerelatively large quantities of bone marrow.

The terms “insertion site,” “penetration site,” and “installation site”may be used in this application to describe a location on a bone atwhich an intraosseous device may be inserted or drilled into the boneand associated bone marrow. Insertion sites, penetration sites andinstallation sites are generally covered by skin and soft tissue.

The term “intraosseous (IO) device” may be used in this application toinclude, but is not limited to, any hollow needle, hollow drill bit,penetrator assembly, bone penetrator, catheter, cannula, trocar, stylet,inner penetrator, outer penetrator, IO needle, biopsy needle, aspirationneedle, IO needle set, biopsy needle set or aspiration needle setoperable to provide access to an intraosseous space or interior portionsof a bone. Such IO devices may be formed, at least in part, from metalalloys such as 304 stainless steel and other biocompatible materialsassociated with needles and similar medical devices.

Various types of IO devices may be formed in accordance with teachingsof the present disclosure. Examples of such IO devices may include, butare not limited to, biopsy needles, biopsy needle sets, aspirationneedles and aspiration needle sets. However, a wide variety of other IOdevices may be formed in accordance with one or more teachings of thepresent disclosure. Such IO devices may or may not include a trocar orstylet.

For some applications, a trocar or stylet may be inserted into agenerally hollow, longitudinal bore or lumen in an associated catheteror cannula. The first end of the second hub may be releasably engagedwith second end of the first hub to releasably dispose the stylet ortrocar within the longitudinal bore of the cannula or catheter. Thepresent disclosure is not limited to aspiration needle sets 100 orbiopsy needle sets 100 a as discussed in this application.

The term “target area” may be used in this application to describeselected portions of a bone cavity or locations in a bone cavity fromwhich associated bone marrow may be harvested in accordance withteachings of the present disclosure.

Many currently available techniques for harvesting bone and/or bonemarrow may require more than one penetration into a bone and associatedbone marrow to retrieve an adequate sample of bone and/or bone marrow.Multiple penetration sites may be required in the same bone if a biopsyspecimen is not satisfactorily retrieved at the first penetration site.Medical personnel may need to insert an IO needle into several differentpenetration sites on the same bone to obtain adequate quantities of bonemarrow for transplant or stem cell research. For example obtainingsufficient quantities of bone marrow from a patient's pelvis may requiresix or more insertion sites. Multiple insertions may be extremelypainful for a patient and may deter some people from donating bonemarrow. Multiple insertions may also cause fatigue in medical personnelperforming such procedures with manual IO devices.

Bone marrow transplant procedures and various research procedures suchas stem cell research often require relatively large quantities of boneand/or bone marrow. Hip bones generally have a large bone cavity and aretherefore frequently used as a target area for harvesting bone marrowfor transplant procedures, stem cell research procedures or any otherprocedure requiring relatively large quantities of bone marrow.

For some applications, an IO needle or other IO device may be formedwith a first end operable to penetrate bone and/or associated bonemarrow. A connector or hub may be attached to a second end of the IOneedle or other IO device. Such connectors or hubs may be operable toreleasably engage the IO needle or IO device with a powered driver, amanual driver and/or a coupler assembly.

IO needle sets and other IO devices incorporating teachings of thepresent disclosure may include a first IO device such as a cannula,catheter or outer penetrator and a second IO device such as a stylet,trocar or inner penetrator. Various types of cutting surfaces may beformed proximate a first end of the first IO device and a first end ofthe second IO device. The cutting surface of the first IO device and thecutting surface of the second IO device may cooperate with each other topenetrate bone and/or associated bone marrow.

A first connector or first hub may be used to releasably engage thefirst IO needle or IO device with the second IO needle or IO device. Forexample an IO needle set may include a first connector or a first hubwith a generally hollow cannula, catheter or outer penetrator attachedthereto and extending from a first end of the first hub. A second end ofthe first hub may be operable to be releasably engaged with a first endof a second connector or a second hub. A stylet, trocar or innerpenetrator may also be attached to and extend from the first end of thesecond hub. The second end of the first hub may include an opening sizedto allow inserting the stylet, trocar or inner penetrator through theopening and a lumen in the cannula, catheter or outer penetrator.

A second end of the second hub may be operable to be releasably engagedwith a first end of a coupler assembly incorporating teachings of thepresent disclosure. One end of a shaft extending from a powered driveror a manual driver may be releasably engaged with a second end of thecoupler assembly.

Additional details concerning powered drivers, connectors, hubs, and IOdevices may be found in copending patent application entitled “PoweredDriver Intraosseous Device and Methods To Access Bone Marrow” filed______ Ser. No. ______ which claims priority from a provisional patentapplication with the same title filed on Apr. 4, 2007.

Various features of the present disclosure may be described with respectto powered driver 200, coupler assemblies 250, 250 a, 250 b and 250 c,hub assemblies 130, 130 a, 130 b and 130 c, IO needle sets 100, 100 aand 100 b, biopsy needle 100 c and/or containment bag 170. However, thepresent disclosure is not limited to such powered drivers, couplerassemblies, hub assemblies, IO needle sets, biopsy needles and/orcontainment bags. A wide variety of intraosseous devices, hubassemblies, coupler assemblies and/or containment bags may be formed inaccordance with teachings of the present disclosure with variousdimensions and/or configurations.

FIGS. 1A-1J show some examples of medical procedure trays and/or kitswhich may contain one or more intraosseous devices and/or othercomponents incorporating teachings of the present disclosure. Forexample, medical procedure tray 20 a as shown in FIG. 1A may includeintraosseous needle set or aspiration needle set 100 incorporatingvarious teachings of the present disclosure. Medical procedure tray 20 bas shown in FIG. 1B may include intraosseous needle set or biopsy needleset 100 b, ejector 90, funnel 80 and/or containment bag or sterilesleeve 170. Medical procedure tray 20 c as shown in FIGS. 1C-1I may alsoinclude various IO devices and other components incorporating teachingsof the present disclosure including, but not limited to, biopsy needleset 100 b, coupler assembly 250, containment bag 170, ejector 90 and/orfunnel 80 a.

Medical procedure trays and/or kits formed in accordance with teachingsof the present disclosure may provide a support or base for variouscomponents such as a coupler assembly, funnel and/or sharps protector toallow an operator or user to perform various functions without requiringthat the operator or user hold or manipulate the respective component.For example medical procedure tray 20 c as shown in FIG. 1 may positionand support coupler assembly 250 such that one end of a powered drivermay be inserted (pushed) into releasable engagement with second end 252of coupler assembly 250. The powered driver may then be used to withdrawcoupler assembly 250 from medical procedure tray 20 c without requiringan operator or user to directly hold or manipulate coupler assembly 250.

Funnel 80 a may be positioned and supported within medical proceduretray 20 c such that one end of an intraosseous device may be inserted(pushed) into funnel 80 a. Funnel 80 a may be withdrawn from medicalprocedure tray 20 c without requiring that an operator or user directlyhold or manipulate funnel 80 a. Each sharps protector 64 a may also bepositioned and supported within medical procedure tray 20 c to allowinserting (pushing) one end of an intraosseous device or any othermedical device requiring sharps protection into sharps protector 64 awithout requiring that an operator or user to directly hold ormanipulate the associated sharps protector 64 a. Medical proceduretrays, coupler assemblies and other components formed in accordance withteachings of the present disclosure may substantially reduce the numberof opportunities for an accidental “needle stick” and/or dropping,contaminating or other problems associated with handling andmanipulating various components disposed within an associated medicalprocedure tray.

Medical procedure trays and kits formed in accordance with teachings ofthe present disclosure may have a wide variety of configurations and/ordimensions. For some applications, a kit holding intraosseous devices inaccordance with teachings of the present disclosure may have an overalllength of approximately four and one-half inches, a width ofapproximately three inches and a depth of approximately two inches.Various heat sealing techniques may be satisfactorily used to place aremovable cover (not expressly shown) over a medical procedure tray orkit incorporating teachings of the present disclosure.

Medical procedure trays 20 a, 20 b and/or 20 c may also contain a widevariety of other components including, but not limited to, one or moresharps protectors 64 as shown in FIGS. 1A and 1B or sharps protectors 64a as shown in FIGS. 1C, 1E and 1F. Sharps protectors 64 and 64 a mayinclude hard foam or claylike material 66 disposed therein. Intraosseousdevices such as aspiration needle sets and biopsy needle sets typicallyhave respective sharp tips and/or cutting surface operable to penetrateskin, soft tissue and bone. The sharp tips and/or cutting surface ofsuch intraosseous devices may be inserted into hard foam or claylikematerial 66 after completion of a medical procedure using the respectiveintraosseous device.

For some applications, medical procedure tray 20 a may be referred to asa “bone marrow aspiration tray,” “aspiration procedure tray” or “bonemarrow aspiration kit”. For some applications, medical procedure trays20 b and 20 c may sometimes be referred to as “bone and/or bone marrowbiopsy procedure trays” or “biopsy procedure trays” or “bone marrowbiopsy kits.”

Medical procedure trays 20 a, 20 b and/or 20 c may be formed fromvarious polymeric materials compatible with sterile packaging andstorage of various components disposed within each medical proceduretray. For some applications ethylene oxide sterilization techniques maybe used during assembly and packaging of medical procedure trays 20 a,20 b and 20 c. However, other sterilization procedures may be used asappropriate.

Respective covers (not expressly shown) may be placed over each medicalprocedure tray 20 a, 20 b and 20 c as part of an associatedsterilization and packaging process. Such covers may be removed prior touse of various components disposed within each medical procedure tray.

Medical procedure tray or aspiration tray 20 a (see FIG. 1A) may includeelongated slot 22 with appropriate dimensions for an associatedintraosseous device such as, but not limited to, aspiration needle set100. The dimensions and configuration of slot 22 may be selected toaccommodate the combined length of hub assembly 130 and cannula 110 aextending therefrom. One end of slot 22 may be sized to accommodate thedimensions and configuration of hub assembly 130. Enlarged openings orfinger slots 24 may also be provided to accommodate inserting andremoving aspiration needle set 100 from slot 22. Various detailsassociated with aspiration needle set 100 will be discussed later withrespect to FIG. 3A.

Sharps protector 64 may be disposed within holder 26 of medicalprocedure tray 20 a. A pair of finger slots 28 may also be formed intray 20 a to accommodate inserting and removing sharps protector 64 fromholder 26 a. Holder 26 b may also be formed in tray 20 a along withassociated finger slots 28. An additional sharps protector or othercomponents may be disposed within holder 26 b. Thedimensions/configurations of slot 22 and holders 26 a and 26 b may bevaried as desired for respective components which will be disposedtherein.

Medical procedure tray or biopsy tray 20 b (See FIG. 1B) may includeelongated slots 30 and 32. The dimensions and configuration of elongatedslot 30 may be selected to accommodate placing ejector 90 therein. Thedimensions and configuration of elongated slot 32 may be selected toaccommodate placing intraosseous device or biopsy needle set 100 btherein.

One end of elongated slot 30 may have configuration and dimensionsselected to accommodate the configuration and dimensions of handle 96disposed on second end 92 of injector rod 94. A pair of finger slots 34may be formed as part of elongated slot 30 to allow installing andremoving ejector 90. One end of elongated slot 32 may be operable toaccommodate the configuration and dimensions associated with hubassembly 130 a of biopsy needle set 100 b. A pair of finger slots 36 mayalso be provided as part of elongated slot 32 to accommodate insertingand removing biopsy needle set 100 b from elongated slot 32.

Tray 20 b may also include holder 38 disposed adjacent to elongated slot30. Holder 38 may have a configuration and dimensions compatible withreleasably placing funnel 80 therein. Tray 20 b may also includecompartment or holder 40 with dimensions compatible with placingcontainment bag 170 with coupler assembly 250 attached thereto. One ormore specimen or sample containers or cups (not expressly shown) may beprovided in biopsy tray 20 b. Biopsy specimen or sample containers mayinclude a cavity sized to receive a biopsy specimen from biopsy needleset 100 b. Funnel holders 38 may be formed in biopsy procedure tray 20 badjacent to ejector 90 to ensure that funnel 80 is readily available toassist with removing a biopsy specimen from biopsy needle set 100 b.

Medical procedure tray or biopsy tray 20 c as shown in FIGS. 1C-1Irepresents another example of a medical procedure tray formed inaccordance with teachings of the present disclosure. Biopsy proceduretray 20 c may include intraosseous device or biopsy needle set 100 breleasably disposed in elongated slot 42 and ejector 90 disposed inelongated slot 44. Respective ends of elongated slots 42 and 44 may bedisposed adjacent to each other so that finger slots 46 a, 46 b and 46 cmay be more easily manufactured. Biopsy procedure tray 20 c alsoincludes a pair of sharps protectors 64 a disposed in respective holders48. Each holder 48 includes a pair of finger slots 50.

Funnel 80 a may be slidably disposed in holder 56 in medical proceduretray 20 c in a generally vertical position. See FIG. 1D. As a result,first end 81 a of funnel 80 a may be oriented in a position to allowinserting one end of biopsy needle set 100 b or outer cannula 110 btherein. Longitudinal passageway 84 proximate first end 81 a may includea sticking tapered portion operable to maintain contact with one end ofbiopsy needle set 100 b or outer cannula 110 b. Biopsy needle set 100 bor cannula 110 b may then be manipulated to pull funnel 80 a from holder56. Funnel 80 a may serve as a sharps protector for the one end of anintraosseous device inserted therein.

One of the benefits of the present disclosure may include being able toreleasably engage one end of a powered driver with one end of a couplerassembly, releasably engage one end of a biopsy needle with an oppositeend of the coupler assembly, insert another end of the biopsy needleinto a selected target area, “power out” the biopsy needle with a highdegree of confidence that a biopsy specimen will be disposed therein andinsert the other end of the biopsy needle into a funnel to provide bothsharps protection and removal of the biopsy specimen. Any direct contactbetween an operator and the biopsy needle may be limited to pushing theone end of the biopsy needle into a respective end of the couplerassembly.

A pair of holders or clamps (not expressly shown) may also be formed inmedical procedure tray 20 c adjacent to holder for coupler assembly 250.Such clamps may be designed to accommodate first end 181 and second end182 of flexible stay 180 disposed on second opening 172 of containmentbag 170. Coupler assembly 250 may also be installed in holder 58 ofbiopsy procedure tray 20 c with first end 251 down and second end 252looking up.

FIGS. 1E and 1F show one procedure for placing a powered driver within acontainment bag incorporating teachings of the present disclosure.Containment bag 170 may be formed from generally flexible, fluidimpervious material which may also be sterilized using conventionalsterilization techniques. Containment bag 170 may be used to prevent anon-sterile powered driver from contaminating a sterile intraosseousdevice and/or an injection site, particularly during a bone marrowbiopsy procedure or a bone marrow aspiration procedure. Containment bag170 may be operable to form a fluid barrier with adjacent portions ofhousing assembly 270. At the same time, coupler assembly 250 may allowpowered driver to rotate an intraosseous device releasably engaged withfirst end 251 of coupler assembly 250 without damage to containment bag170.

First opening 171 may be formed along one edge of containment bag orsleeve 170. Second opening 172 may be formed along an opposite edge ofcontainment bag 170. The configuration and dimensions of second opening172 may be selected to accommodate inserting and removing a powereddriver or other non-sterile medical device therefrom.

Coupler assembly 250 may be securely engaged with and extend from firstopening 171. The attachment between adjacent portions of first opening171 and coupler assembly 250 may be selected to allow rotation of anintraosseous device by an associated powered drive. Housing assembly 270and/or housing segments 280 and 290 of coupler assembly 250 may remainrelatively stationary during rotation of elongated core 260. See FIG.5F. For example portions of housing assembly 270 such as flange 254extending from second end 252 of coupler assembly 250 may be attached tofirst opening 171 and remain relatively stationary while powered driver200 rotates elongated core 260 and aspiration needle set 100 extendingtherefrom.

For some applications, powered driver 200 may be directly placed into acontainment bag and engaged with coupler assembly 250. For otherapplications, a non-sterile powered driver may be inserted intocontainment bag 170 in connection with removing coupler assembly 250from a medical procedure tray.

For some applications, a protective cover (not expressly shown) may beremoved from medical procedure tray 20 c. End 224 extending from driveshaft 222 of powered driver 200 may then be inserted through secondopening 172 of containment bag 170 and releasably engaged with secondend 252 of coupler assembly 250.

First end 181 and second end 182 of flexible stay 180 may then beremoved from respective clamps or holders in medical procedure tray 20 cto allow manually lifting second opening 172 upwardly relative topowered driver 200. See FIG. 1E. Containment bag 170 may continue to beraised to a fully extended position with powered driver 200 disposedtherein. See FIG. 1F. Flap 174 may then be placed over second opening172. Containment bag 170 with powered driver 200 disposed therein andcoupler assembly 250 may then be removed from holder 58 of medicalprocedure tray 20 c.

FIGS. 1G-1J show another procedure incorporating teachings of thepresent disclosure to place a non-sterile powered driver into acontainment bag with a coupler assembly or port assembly extendingtherefrom and enclosing the non-sterile powered driver within thecontainment bag to allow engaging the coupler assembly with a sterileintraosseous device. The same procedure may be used to engage othernon-sterile medical devices with sterile medical devices.

For some applications, medical procedure tray 20 c may be placed insecond tray 20 d with first drape 51 disposed therebetween. See FIGS. 1Gand 1J. Second drape 52 with opening or fenestration 54 may then beplaced over medical procedure tray 20 c with opening or fenestration 54generally aligned with second opening 172 of containment bag 170 andsecond end 252 of coupler assembly 250. Second drape 52 may also coverportions of first drape 51 extending outwardly from between medicalprocedure tray 20 c and the second medical procedure tray (not expresslyshown).

For some applications portions of second drape 52 adjacent tofenestration 54 may be releasably engaged with portions of containmentbag 170 adjacent to second opening 172. See FIG. 1J. Variouscommercially available low strength adhesive materials may besatisfactorily used to provide releasable engagement between seconddrape 52 proximate fenestration 54 and second opening 172 of containmentbag 170.

First drape 51 and second drape 52 may then be folded with each otherand covering the contents of medical procedure tray 20 c such as shownin FIG. 1G. A portion of second drape 52 may be seen in FIG. 1G betweenrespective portions of first drape 51.

A protective cover (not expressly shown) may then be placed over bothmedical procedure trays and any exposed portions of drapes 51 and 52.The combined medical procedure tray (not expressly shown) may then besterilized. One benefit of such sterilization include, but is notlimited to, providing a sterilized containment bag which may be used toengage a non-sterile medical device with a sterile medical device inaccordance with teachings of the present disclosure.

First drape 51 and second drape 52 may then be unfolded as shown in FIG.1H which will expose second opening 172 of containment bag 170 andsecond end 252 of coupler assembly 250 through fenestration 54 in seconddrape 52. A non-sterile person (not expressly shown) may next insertnon-sterile powered driver 200 through opening or fenestration 54 andreleasably engage end 224 of drive shaft 222 extending from non-sterilepowered driver 200 with second end 252 of coupler assembly 250. Thenon-sterile person may then lift second drape 52 to a position such asshown in FIG. 1J with powered driver 200 disposed within containment bag170. The non-sterile person may continue to lift second drape 52 torelease engagement between portions of second drape 52 adjacent tofenestration 54 and portions of containment bag 170 adjacent to secondopening 172.

Typical procedures associated with using a medical procedure tray or kitincorporating teachings of the present disclosure may include thefollowing steps. Medical procedure tray 20 d at a desired location forperforming an associated medical procedure. For example medicalprocedure tray 20 d may be placed on a table or cart adjacent to asurgical table on which a bone marrow aspiration procedure or a bonemarrow biopsy procedure may be performed.

An associated cover may be removed from medical procedure tray 20 d by asterile person to expose folded drapes 51 and 52. Drapes 51 and 52 maythen be unfolded by the sterile person such as shown in FIG. 1H. Anon-sterile person may then pick up non-sterile powered driver 200 andinsert powered driver 200 through fenestration 54 in second drape 52such as shown in FIG. 1H. End 224 of drive shaft 222 of powered driver200 may “snap” into place within second end 252 of coupler assembly 250.The non-sterile person may then lift second drape 52 such as shown inFIG. 1J which will result in lifting containment bag 170 up and overpowered driver 200. The non-sterile person may then remove second drape52.

A sterile person may next close flap 174 over second end 172 ofcontainment bag 170. The sterile person may then grasp handle 214 ofpowered driver 200 through containment bag 170 and lift powered driver200 with coupler assembly 250 attached thereto from holder 58 disposedin kit 20 c. The sterile person may then remove an intraosseous devicesuch as biopsy needle set 100 b from medical procedure kit 20 c andinsert second end 102 of biopsy needle set 100 b into first end 251 ofcoupler assembly 250. A “snap” may be felt when second end 102 of biopsyneedle set 100 b (or any other intraosseous device incorporatingteachings of the present disclosure) is releasably latched within firstend 251 of coupler assembly 250. A needle safety cap (not expresslyshown) may be removed from first end 101 of biopsy needle 100 b afterreleasably engaging second end 102 with first end 251 of couplerassembly 250.

Powered driver 200 disposed within containment bag 170 along withcoupler assembly 250 and biopsy needle set 100 b extending there frommay be held in one hand while a sterile person identifies the insertionsite with the other hand. Powered driver 200 may be positioned over theinsertion site to introduce first end 101 of biopsy needle set 100 bthrough the skin in the direction and towards the bone. Upon contactwith the bone the operator may squeeze button or trigger 246 and applyrelatively steady gentle pressure to handle 214 of powered driver 200.Upon penetration of the bone cortex, the operator may release trigger246 to stop further insertion of first end 101 of biopsy needle set 100b.

First housing segment 280 may then be activated to release second end102 of biopsy needle set 100 b from engagement with coupler assembly250. Second hub 150 a may then be rotated counterclockwise to disengagesecond hub 150 a and associated stylet 120 from first hub 140 a. SeeFIG. 3B. Stylet 120 may then be pulled out and removed from biopsyneedle or cannula 110 b. First end 121 of stylet 120 may then beinserted into sharps protector 64 a. Upon completion of an appropriatebiopsy procedure second hub 150 a may be reengaged with first hub 140 a.First end 251 of coupler assembly 250 may then be reengaged with secondend 102 of biopsy needle set 100 b to rotate or spin biopsy needle set100 b while withdrawing from the insertion site. After removal from theinsertion site, second end 102 of biopsy needle set 100 b may bedisengaged from coupler assembly 250. First end 101 of biopsy needle set100 b may then be inserted into sharps container 64 a.

After second drape 52 has been removed from engagement with secondopening 172, a sterile person (not expressly shown) may close flap 174to seal non-sterile powered driver therein. The sterile person may thenremove containment bag 170, powered driver 200 and coupler assembly 250from holder 58. The sterile person may then releasably engage first end251 of coupler assembly 250 with one end of a sterile intraosseousdevice disposed within medical procedure tray 20 c in accordance withteachings of the present disclosure. After completion of a bone marrowaspiration procedure, bone and/or bone marrow biopsy procedure and/orother medical procedures using the intraosseous device, the sharp end orsharp tip of the intraosseous device may be inserted into material 66 insharp protector 64 a for further disposal in accordance with theappropriate procedures.

A wide variety of drapes may be satisfactory used with a medicalprocedure tray or kit incorporating teachings of the present disclosure.One example of a drape associated with medical procedures is shown inU.S. Pat. No. 4,553,539. However, first drape 51 and/or second drape 52may be formed from a wide variety of materials and may have a widevariety of configurations and/or dimensions.

Powered driver 200 as shown in FIGS. 1E, 1F, 1I, 2, and 5A and powereddriver 200 a as shown in FIGS. 7A and 7B may be satisfactorily used toinsert an intraosseous device incorporating teachings of the presentdisclosure into a bone and associated bone marrow. Powered drivers 200and 200 a may be substantially similar except for respective ends 224and 224 a of drive shaft 222 extending from first end 211 of housing210. See for example FIGS. 2 and 7A. Therefore, only powered driver 200will be described in more detail.

Powered driver 200 may include housing 210 having a generalconfiguration similar to a small pistol defined in part by handle 214.Various components associated with powered driver 200 may be disposedwithin housing 210 including handle 214. For example a power source suchas battery pack 216 may be disposed within handle 214. Battery pack 216may have various configurations and dimensions.

Housing 210 including handle 214 may be formed from relatively strong,heavy duty polymeric materials such as polycarbonate or othersatisfactory materials. For some applications housing 210 may be formedin two halves (not expressly shown) which may be joined together with afluid tight seal to protect various components of powered driver 200disposed therein.

Motor 218 and gear assembly 220 may be disposed within portions ofhousing 210 adjacent to handle 214. Motor 218 and gear assembly 220 maybe generally aligned with each other. Motor 218 may be rotatably engagedwith one end of gear assembly 220. Drive shaft 222 may be rotatablyengaged with and extend from another end of gear assembly 220 oppositefrom motor 218. For some applications both motor 218 and gear assembly220 may have generally cylindrical configurations.

Motors and gear assemblies satisfactory for use with powered driver 200may be obtained from various vendors. Such motor and gear assemblies maybe ordered as “sets” with one end of each motor securely attached to anadjacent end of an associated gear assembly. A drive shaft havingvarious dimensions and/or configurations may extend from the gearassembly opposite from the motor. Such gear assemblies may sometimes bereferred to as “reduction gears” or “planetary gears”. The dimensionsand/or configuration of housing 210 may be modified to accommodate anassociated motor and gear assembly.

Distal end or first end 211 of housing 210 may include an opening (notexpressly shown) with portions of drive shaft 222 extending therefrom.For some applications end 224 or the portion of drive shaft 222extending from first end 211 of housing 210 may have a generallyhexagonal cross section with surfaces 226 disposed thereon. Receptacle263 disposed in second end 252 of coupler assembly 250 may have amatching generally hexagonal cross section. See FIG. 5E.

Surfaces 226 may extend generally parallel with each other and parallelwith respect to a longitudinal axis or rotational axis (not expresslyshown) associated with drive shaft 222. One or more tapered surfaces 228may also be formed on end 224 to assist with releasably engaging powereddriver 200 with coupler assembly 250. See FIGS. 5E and 5G. The end of adrive shaft extending from a powered driver may have a wide variety ofconfigurations. See for example FIGS. 6A and 6B.

A drive shaft having desired dimensions and configuration may extendfrom the gear assembly opposite from the motor. The drive shaft may beprovided as part of each motor and gear assembly set. The dimensionsand/or configuration of an associated housing may be modified inaccordance with teachings of the present disclosure to accommodatevarious types of motors, gear assemblies and/or drive shafts. Forexample, powered drivers used with aspiration needles and/or biopsyneedles may include gear assemblies with larger dimensions required toaccommodate larger speed reduction ratios, for example between 60:1 and80:1, resulting in slower drive shaft RPM's. Powered drivers used toprovide intraosseous access during emergency medical procedures mayoperate at a higher speed and may include gear assemblies having asmaller speed reduction ratio, for example between 10:1 and 30:1,resulting in higher drive shaft RPM's. For some applications, thedifference in size for gear assemblies may result in increasing theinside diameter of an associated housing by approximately two to threemillimeters to accommodate larger gear assemblies associated withpowered drivers used to insert biopsy needles and/or aspiration needles.

Coupler assemblies having corresponding openings or receptacles may bereleasably engaged with end 224 extending from first end 211 of powereddriver 200 or end 224 a extending from first end 211 of powered driver200 a. For example, end 224 extending from first end 211 of housing 210may be releasably engaged with receptacle 264 disposed proximate secondend 252 of coupler assembly 250 as shown in FIGS. 1E, 1F, 5C and 5D.

For some applications thrust bearing 241 may be disposed between firstend or distal end 211 of housing 210 and adjacent portions of gearassembly 220. Thrust bearing 242 may be disposed between second end orproximal end 212 of housing 210 and adjacent portions of motor 218.Thrust bearings 241 and 242 may limit longitudinal movement of motor218, gear assembly 220 and drive shaft 222 within associated portions ofhousing 210.

Trigger assembly 244 may also be disposed within housing 210 proximatehandle 214. Trigger assembly 244 may include trigger or contact switch246. Motor 218 may be energized and deenergized by alternatelydepressing and releasing trigger 246. Electrical circuit board 247 mayalso be disposed within housing 210. Electrical circuit board 247 may beelectrically coupled with trigger assembly 244, motor 218, power supply216 and indicator light 248.

For some applications indicator light 248 may be a light emitting diode(LED) or a small more conventional light bulb. For some applicationsindicator light 248 may be activated when ninety percent (90%) ofelectrical storage capacity of battery pack 216 has been used.

The configuration and dimensions of an intraosseous device formed inaccordance with teachings of the present disclosure may vary dependingupon respective intended applications for each intraosseous device. Forexample the length of a biopsy needle formed in accordance withteachings of the present disclosure may vary from approximately five (5)millimeters to thirty (30) millimeters. However, biopsy needles havingother lengths may also be formed in accordance with teachings of thepresent disclosure. Aspiration needles formed in accordance withteachings of the present disclosure may have lengths of approximatelytwenty five (25) millimeters, sixty (60) millimeters and ninety (90)millimeters. For some applications an aspiration needle having a lengthof ninety (90) millimeters or more may also include one or more sideports. See for example FIG. 3A. Intraosseous (IO) devices formed inaccordance with teachings of the present disclosure may have outsidediameters and longitudinal bores or lumens corresponding generally witheighteen (18) gauge to ten (10) gauge needles. The configuration anddimensions of each IO device may depend upon the size of an associatedbone and desired depth of penetration of associated bone marrow.

Combining a powered driver with a coupler assembly and an aspirationneedle set in accordance with teachings of the present disclosure mayallow rapid access to the iliac crest or other insertion sites toextract associated bone marrow. Bone marrow aspiration systemsincorporating teachings of the present disclosure may be capable ofinserting an aspiration needle to a desired depth in cancellous bone inten (10) to fifteen (15) seconds. This same capability may be used toobtain bone and/or bone marrow specimens depending upon the optimumspeed for inserting a biopsy needle to obtain a reliable biopsy specimenin accordance with teachings of the present disclosure.

Bone marrow aspiration systems incorporating teachings of the presentdisclosure may provide a powered driver and a coupler assembly operableto insert an aspiration needle into cancellous bone and extract bonemarrow. After an aspiration needle set has been inserted to a desireddepth in a bone for extraction of bone marrow, a trocar or stylet may beremoved from the lumen of an associated catheter or cannula. A hubassembly incorporating teachings of the present disclosure may beattached to the second end of the needle set allows relatively easy andquick removal of the trocar or stylet from the lumen of the cannula orcatheter. A Luer lock fitting provided on a hub attached to the cannulaor catheter may then be connected to a bone marrow aspiration system.See FIG. 10. For some applications hubs and hub assemblies may be formedusing medical grade polycarbonate.

Upon completing aspiration of a desired volume or sample of bone marrowat a first target area, the trocar or stylet may be reinserted into thelumen of the outer penetrator or cannula. The first end of a hubattached to the trocar or stylet may be reengaged with the second end ofa hub attached to the cannula or catheter. A powered driver and couplerassembly incorporating teachings of the present disclosure may then beused to insert the aspiration needle set to a second desired depth inthe cancellous bone to obtain another bone marrow sample or the powereddriver may be used to “power out” the aspiration needle set. Sharpssafety capability for the stylet and/or cannula may be provided as partof such aspiration systems.

Intraosseous (IO) needle sets or aspiration needle sets 100 and 100 a asshown in FIG. 3A and FIG. 3B and biopsy needle 100 c as shown in FIG. 3Crepresent only some examples of intraosseous devices formed inaccordance with teachings of the present disclosure. Aspiration needlesets 100 and 100 a may have similar outer penetrators or cannulas 110 aand similar inner penetrators to stylets 120. See FIGS. 3A and 3B.However, IO needle set 100 may include hub assembly 130 while IO needleset 100 a may include hub assembly 130 a. See FIGS. 3A and 3B. Biopsyneedle 100 c may also include hub assembly 130 a. See FIG. 3C.

For embodiments represented by IO needle sets 100 and 100 a, first end111 a of cannula 110 a and first end 121 of stylet 120 may be operableto penetrate a bone and associated bone marrow. Various features offirst end 111 a of cannula 110 a and first end 121 of stylet 120 areshown in more detail in FIGS. 3D and 3F. First end 101 of IO needle sets100 and 100 a may correspond generally with first end 111 a of cannula110 a and first end 121 of stylet 120.

Cannula 110 a may have a plurality of markings 104 disposed on exteriorportions thereof. Markings 104 may sometimes be referred to as“positioning marks” or “depth indicators.” Markings 104 may be used toindicate the depth of penetration of aspiration needle set 100 or 100 ainto a bone and associated bone marrow. For some applications cannula110 a may have a length of approximately sixty (60) millimeters and mayhave a nominal outside diameter of approximately 0.017 inchescorresponding generally with a sixteen (16) gauge needle. Cannula 110 amay be formed from stainless steel or other suitable biocompatiblematerials. Positioning marks 104 may be spaced approximately one (1)centimeter from each other on exterior portions of cannula 110 a. Forsome applications one or more side ports 106 may be formed in exteriorportions of cannula 110 a spaced from first end 111 a.

Hub assembly 130 as shown in FIG. 3A may be used to releasably disposestylet 120 within longitudinal bore or lumen 118 of cannula 110 a. SeeFIG. 3E. Hub assembly 130 may include first hub 140 and second hub 150.The second end of cannula 110 a, opposite from first end 111 a, may besecurely engaged with the second end of cannula 110 a. The second end ofstylet 120, opposite from first end 121, may be securely engaged withthe first end of hub 150.

As shown in FIG. 3A cannula 110 a may extend longitudinally from firstend 141 of hub 140. Stylet 120 may also extend from the first end of hub150 (not expressly shown). The second end of hub 140 may include astandard Luer lock fitting which may be releasably engaged with acorresponding Luer lock fitting disposed within the first end of secondhub 150. Dotted lines 134 as shown in FIG. 3A may represent theresulting threaded connection between the second end of first hub 140and the first end of second hub 150. Examples of Luer lock connectionsand/or fittings are shown in more detail in FIGS. 3B, 3C, 5E, 5F, 5I and10. The Luer lock fitting disposed on the second end of hub 140 may beoperable to be releasably engaged with a standard syringe type fittingand/or a standard intravenous (IV) connection.

Hub 150 includes second end 152 which generally corresponds with secondend 132 of hub assembly 130 and second end 102 of IO needle set 100. Hub140 may include first end 141 which may generally correspond with firstend 131 of hub assembly 130. Cannula 110 a may extend longitudinallyfrom first end 141 of hub 140 and first end 131 of hub assembly 130.

Various types of receptacles may be satisfactory disposed in second end152 of hub 150 for use in releasably engaging hub assembly 130 with apowered driver. For example, a receptacle having a generally taperedconfiguration corresponding with the tapered configuration of one end ofa drive shaft extending from a powered driver may be releasably engagedwith second end 152 of hub 150. Powered driver 200 a as shown in FIGS.6A and 6B may represent one example of a powered driver having a driveshaft extending from a housing with a tapered portion operable to bereleasably engaged with a receptacle having a corresponding generallytapered configuration. For some applications such powered drivers may besecured to an intraosseous device by a magnet (not expressly shown)disposed on the end of the tapered shaft extending from the powereddriver and a metal disk disposed within a corresponding receptacle inthe intraosseous devices. Such powered drivers may also be used withintraosseous devices used to obtain emergency vascular access (EVA).

For other embodiments which may be discussed later, in more detail, thesecond end of a hub assembly may be operable to be disposed within areceptacle formed in a coupler assembly incorporating teachings of thepresent disclosure. One feature of the present disclosure may includeforming a hub assembly which may be releasably engaged within a firstreceptacle disposed in a first end of a coupler assembly. See forexample receptacle 263 proximate first end 261 of elongated core 260 asshown in FIG. 5E. The dimensions and configuration of receptacle 263 maybe selected to prevent rotation of hub 150 a relative to hub 140 a whileinserting (rotating) an IO device into a bone and associated bonemarrow. The powered driver may be releasably engaged with a secondreceptacle disposed in a second end of the coupler assembly. See forexample receptacle 264 proximate second end 262 of elongated core 260 asshown in FIG. 5E.

Intraosseous device or aspiration needle set 100 a is shown in FIG. 3Bwith first end 151 of hub 150 a spaced from second end 142 of hub 140 a.Portions of stylet 120 extending from first end 151 of hub 150 a areshown slidably disposed within lumen or longitudinal bore 118 of cannula110 a.

Hub assembly 130 a as shown in FIG. 3B may include first end 131 whichmay correspond generally with first end 141 of hub 140 a. Hub assembly130 a may also include second end 132 which may correspond generallywith second end 152 of hub 150 a and second end 102 of hub assembly 130a. See FIG. 3B. Cannula 110 a may be attached to and extend from firstend 141 of hub 140 a.

Second end 142 of hub 140 a may include one-half a typical Luer lockconnection or fitting operable to be releasably engaged withcorresponding portions of a Luer lock connection or fitting disposed infirst end 151 of second hub 150 a. For embodiments such as shown inFIGS. 3B and 3C, first end 131 of hub assembly 130 a may correspond withfirst end 141 of first hub 140 a. Second end 152 of second hub 150 a maycorrespond with second end 132 of hub assembly 130 a and second end 102of aspiration needle set 100 a.

At least one portion of hub assembly 130 a may have a generallyhexagonal cross section operable to be received within the generallyhexagonal cross section of receptacle 264 disposed proximate first end251 of coupler assembly 250. See FIG. 5E. For some embodiments portionsof first hub 140 a disposed adjacent to reduced outside diameter portion143 may have generally hexagonal cross sections. See FIGS. 3B and 3C.Various cross sections other than hexagonal may be satisfactorily usedto releasably engage a powered driver with one end of a coupler assemblyand an intraosseous device with an opposite end of the coupler assembly.

Aspiration needle sets may often include a trocar, stylet or penetratorin combination with an associated cannula, catheter or outer penetrator.However, biopsy needles formed in accordance with teachings of thepresent disclosure may or may not include a trocar, stylet or innerpenetrator. For example, biopsy needle 100 c is shown in FIG. 3Cattached to first end of hub 140 a. A stylet or inner penetrator is notattached to first end 151 of hub 150 a.

For embodiments represented by biopsy needle 100 c, hub 140 a may beused to releasably engage biopsy needle 100 c in a receptacle formed ina coupler assembly incorporating teachings of the present disclosure.Hub 150 a may be attached to close of end 141 of hub 140 a. However, formany applications hub 140 a without hub 150 a may be connected with oneend of a coupler assembly in accordance with teachings of the presentdisclosure. Biopsy needle 100 c may be used to capture a biopsy specimenof a bone and associated bone marrow. Placing a trocar within biopsyneedle 100 c may result in substantial damage to the bone specimenduring penetration of the bone by the combined tips of the trocar andbiopsy needle 100 c.

Hub 140 a may include second end 142 with opening 144 formed therein.Passageway 146 may extend from second end 142 towards first end 141 ofhub 140 a. See FIGS. 5E, 5F and 5I. Passageway 146 may be operable tocommunicate fluids with lumen 118 of cannula 100 a. Second end 142 ofhub 140 may include various features of a conventional Luer lockconnection or fitting, including threads 148. Corresponding threads 158may be formed within first end 151 of hub 150 a. See for example FIGS.5E, 5F and 5I. The dimensions and configuration of receptacle 263 infirst end 251 of coupler assembly 250 may be selected to preventrelative movement between hub 140 a and hub 150 a during insertion(rotation) of an IO device into a bone and associated bone marrow. Ifsuch relative movement occurs, threads 148 and 158 may be disconnected.

For some applications hub 140 a and hub 150 a may be formed usinginjection molding techniques. For such embodiments hub 140 a may includereduced outside diameter portion 143 disposed between first end 141 andsecond end 142. See for example FIGS. 3B, 3C and 5C. In a similar mannera plurality of void spaces or cutouts 153 may be formed in hub 150 aadjacent to and extending from second end 152 in the direction of firstend 151. See for example FIGS. 3B, 3C and 5A. The configuration anddimensions of reduced diameter portion 143 and/or cutouts 153 may bevaried to optimize associated injection molding techniques and at thesame time provide required configurations, dimensions and materialstrength to allow associated hub assembly 130 a to function inaccordance with teachings of the present disclosure.

FIGS. 3D and 3E show one example of cutting surfaces and tips which maybe formed adjacent to the ends of a cannula and an associated trocar inaccordance with teachings of the present disclosure. For embodimentsrepresented by cannula or outer penetrator 110 a and trocar or innerpenetrator 120 a, tip 123 of stylet 120 may be disposed relatively closeto tip 113 of cannula 110 a. For some applications, first end 121 oftrocar 120 and first end 111 a of cannula 110 a may be ground at thesame time to form adjacent cutting surfaces 114 and 124. Grinding ends111 a and 121 at the same time may result in forming a single cuttingunit to form generally matching cutting edges 124 e and 114 e such asshown in FIGS. 3D and 3E. Other types of cutting surfaces formed inaccordance with teachings of the present disclosure may be discussedlater.

First end 121 of trocar 120 may extend through opening 144 in second end142 of hub 140 a. See FIG. 3B. Hub 150 a disposed on the second end oftrocar 120 may be releasably engaged with the second end of cannula 110a represented by hub 140 a. See FIG. 3B.

Oncologists and other health care provides may be unable to successfullyobtain a suitable specimen of bone and/or bone marrow because currentlyavailable biopsy needles sometimes fail to capture a satisfactoryspecimen of bone and/or bone marrow. When a specimen is obtained, thespecimen may sometimes be damaged or contaminated. Intraosseous devicesincorporating teachings of the present disclosure may substantiallyreduce or eliminate problems associated with obtaining a suitablespecimen of bone and/or bone marrow. Various teachings of the presentdisclosure may substantially increase the probability of obtaining asatisfactory biopsy specimen of cancellous bone and associated bonemarrow.

Human bones may generally be described as having a hard outer lamellaeor layer of osseous tissue known as “cortical bone”. Cancellous bone(also known as trabecular or spongy bone) typically fills an innercavity associated with cortical bone. Cancellous bone is another type ofosseous tissue with generally low density and strength but high surfacearea. Cancellous bone typically includes spicules or trabeculae whichform a latticework of interstices filled with connective tissue or bonemarrow. Exterior portions of cancellous bone generally contain red bonemarrow which produces blood cellular components. Most of the arteriesand veins of a bone are located in the associated cancellous bone.

One of the benefits of the present disclosure may include providingvarious intraosseous devices including, but not limited to, biopsyneedle sets and biopsy needles operable to reliably obtain biopsyspecimens of cortical bone and/or cancellous bone without significantdamage to associated biopsy specimens. For example, forming a pluralityof cutting surfaces on the extreme end of an outer penetrator or cannulain accordance with teachings of the present disclosure may allow aresulting biopsy needle to more quickly penetrate a bone and associatedbone marrow, may reduce the amount of time and force required to removea bone and/or bone marrow specimen from a target area in accordance withteachings of the present disclosure.

The configuration of the tip of a cannula or outer penetrator may bemodified in accordance with teachings of the present disclosure toprovide optimum torque during insertion of the cannula or outerpenetrator by a powered driver to obtain a bone and/or bone marrowbiopsy specimen. A controlled, steady feed rate when using a powereddriver may result in higher quality biopsy specimens as compared tomanually inserted biopsy needles. At least one helical thread may bedisposed within a hollow cannula proximate an associate tip or first endto assist with capturing a bone and/or bone marrow biopsy specimen.

The quality of a bone and/or bone marrow specimen and reliability ofobtaining a bone and/or bone marrow specimen using a powered driver andbiopsy needle incorporating teachings of the present disclosure may besubstantially improved by using an optimum feed rate for inserting thebiopsy needle into a bone and associated bone marrow. Feed rate or speedof insertion of a biopsy needle incorporating teachings of the presentdisclosure may be a function of the pitch of at least one threaddisposed on an interior portion of the biopsy needle and revolutions perminute (RPM) of the biopsy needle.RPM=Feed rate×Pitch of threads

Helical thread 190 as shown in FIGS. 4C, 4D and 4E may have a pitch ofapproximately twenty four (24) threads per inch. An optimum pitch mayvary based on factors such as reduction gear ratio (77:1 for someembodiments) and load placed on an associated motor.

Further technical benefits may include reducing physical requirementsand mental stress on users and decreasing pain and stress on patients byincreasing speed and control of the needle set insertion during bonemarrow biopsy and bone marrow aspiration procedures.

The combination of a powered driver and a biopsy needle set may be usedto rapidly access the Iliac crest or other insertion sites to extractassociated bone and/or bone marrow specimens. Bone marrow biopsy systemsincorporating teachings of the present disclosure provide a poweredalternative to current manual techniques for inserting biopsy needlesinto bone and bone marrow which are generally considered the industrystandard.

For some applications, an aspiration needle or biopsy needle formed inaccordance with teachings of the present disclosure may include a hollowcannula or catheter having one end formed by electrical dischargemachining (EDM) techniques, grinding techniques and/or other machiningtechniques. A plurality of teeth may be formed on one end of the cannulaor catheter using EDM techniques, grinding techniques and/or othermachining techniques.

For some embodiments a stylet or trocar may also be disposed within thecannula or catheter with a first end of the stylet extending from afirst end of the cannula or catheter. Increasing the length of the firstend of the stylet or trocar extending from the first end of the cannulaor catheter may reduce the amount of torque or force required topenetrate a bone and may reduce time required for an associatedaspiration needle set or biopsy needle set to penetrate the bone andassociated bone marrow.

A specific powered driver, intraosseous device and tip configurationwill generally produce the same torque when drilling in a hard bone or asoft bone. However, the time required to drill to a first depth in ahard bone will generally be greater than the time required to drill tosimilar depth in a soft bone.

For still other embodiments, teeth formed on one end of a cannula orcatheter may be bent radially outward to reduce the amount of timeand/or force required to penetrate a bone and associated bone marrowusing the cannula or catheter. For some applications a powered driverand aspiration needle set or biopsy needle set formed in accordance withteachings of the present disclosure may provide access to a patient'sbone marrow using a similar amount of torque. The length of time forpenetrating a relatively hard bone may be increased as compared with thelength of time required to penetrate a relatively softer bone.

The tips of several stylets and cannulas incorporating teachings of thepresent disclosure were slowly ground with coolant to prevent possiblethermal damage to metal alloys or spring material used to form thestylets and cannulas. The stylets and cannulas were assembled intorespective IO needle sets. The tips of each needle set were insertedinto sawbones blocks under controlled test conditions. Some testing wasconducted with Pacific Research sawbones blocks. The tips of the needlesets were inserted to a depth of approximately two centimeters with tenpounds (10 lbs) of force and twelve volts direct current (12 VDC)applied to an associated powered driver. There was no measurable orvisual wear of the stylet or cannula tips after completion of thetesting.

For some embodiments a generally hollow biopsy needle may besubstantially continuously rotated at an optimum speed or RPM duringinsertion into a selected target area to obtain a biopsy specimen. Thebiopsy needle may include a longitudinal bore extending from a first,open end of the needle to a second, open end of the needle. A smallhelical thread may be formed on interior portions of the longitudinalbore proximate the first end. For some embodiments the thread may have apitch similar to threads used on conventional wood screws. The rate ofrotation or revolutions per minute (RPM) of the biopsy needle may beselected by installing a gear assembly with a desired speed reductionratio (typically between 60:1 and 80:1) between a motor and anassociated drive shaft. For some applications the gear assembly mayreduce speed of rotation of an attached motor at a ratio ofapproximately 66:1 or 77:1.

Outer penetrator or cannula 110 f as shown in FIG. 3F may include firstend 111 f having a plurality of cutting surfaces 114 f formed adjacentto opening 116 in first end 111 f. Opening 116 may communicate with andform a portion of an associated longitudinal bore or lumen 118. For someapplications cutting surfaces 114 f may be formed using electricaldischarge machining (EDM) techniques.

For embodiments such as shown in FIG. 3G, outer penetrator or cannula110 g may include first end 111 g having a generally taperedconfiguration or reduced outside diameter as compared with otherportions of cannula 110 g. A plurality of cutting surfaces 114 g may bedisposed on end 111 g adjacent to respective opening 116. For someapplications, cutting surfaces 114 g may be formed using machinegrinding techniques. For embodiments end 111 g of cannula 110 g mayinclude six ground cutting surfaces 114 g with respective crowns 115 maybe formed therebetween. Forming a biopsy needle set and/or biopsy needlewith tapered end 111 g and a plurality of cutting surfaces 114 g andcrowns 115 may provide improved drilling performance when the resultingbiopsy needle set and/or biopsy needle is used with a powered driver inaccordance with teachings of the present disclosure.

For some applications, helical groove 117 may be formed withinlongitudinal bore 118 proximate respective opening 116. Helical groove117 may assist with retaining a biopsy specimen or a bone marrowspecimen within longitudinal bore 118.

Testing conducted with cannulas or outer penetrators formed inaccordance with teachings of the present disclosure indicated thatforming cutting surfaces or cutting teeth with electrical dischargemachining (EDM) sometimes resulted in the associated cannula or outerpenetrator being able to drill through a bone and associated bone marrowslightly faster than a cannula or outer penetrator having cuttingsurfaces formed using grinding techniques. Some test results alsoindicated that bending cutting surfaces formed on one end of a cannulaor outer penetrator in accordance with teachings of the presentdisclosure may reduce the amount of time and/or the amount of forcerequired to remove a bone and/or bone marrow specimen from a targetarea.

Intraosseous needle set or biopsy needle set 100 g is shown in FIGS. 3Iand 3J. Biopsy needle set 100 g may include cannula or outer penetrator110 g with stylet or inner penetrator 120 g slidably disposed therein.First end 101 of biopsy needle set 110 g is shown in FIGS. 3I and 3J.For some applications first end 101 of biopsy needle set 100 g mayminimize damage to skin and soft body tissue at an insertion site.

For some applications inner penetrator or trocar 120 g may include firstend 121 having a plurality of cutting surfaces 125 and 126 formed onexterior portions thereof extending from associated tip 123 towardssecond end of trocar or inner penetrator 120 g. For some applicationsone or more cutting surfaces 125 may be formed having length 127extending from tip 123 to associated cutting surfaces 114 g inassociated cannula 110 g. One or more cutting surfaces 126 may be formedadjacent to each cutting surface 125 with second length 128. Firstlength 127 may be greater than second length 128. The ratio of firstlength 127 and second length 128 may be varied in accordance withteachings of the present disclosure to provide optimum performance forpenetrating a selected bone and associated bone marrow.

For some applications, a single thread may be disposed within thelongitudinal bore or lumen of a biopsy needle, cannula, catheter orouter penetrator in accordance with teachings of the present disclosure.Various techniques and procedures may be satisfactorily used to placethe single thread within a generally hollow cannula or outer penetratorproximate one end of the cannula or outer penetrator having one endoperable to penetrate a bone and/or associated bone marrow. For someembodiments, a helical coil having a configuration and dimensionsassociated with the resulting single thread may be placed on one end ofa mandrel such as a spot welding electrode assembly. The mandrel orelectrode assembly may then be inserted through an opening in the oneend of the cannula or outer penetrator operable to penetrate a boneand/or associated bone marrow. The helical coil may then be bonded withadjacent portions of cannula. Coils having a wide variety of dimensionsand configurations may be satisfactorily used to place a single threadin a biopsy needle.

For embodiments such as shown in FIGS. 4A-4E, examples of helicalthreads are shown disposed in biopsy needles or cannulas incorporatingteachings of the present disclosure. Outer penetrator or cannula 110 has shown in FIG. 4A may be formed with longitudinal bore 118 or lumen118 extending from open 116 through cannula 110 h. Electrode assembly ormandrel 160 may be used to install (spot weld) a single helical threadin lumen 118 proximate opening 116.

Helical coil 192 as shown in FIG. 4B may be placed on first end 161 ofelectrode assembly 160. Helical coil 192 may have the cross section of aright triangle. First end or copper electrode 161 may have anappropriate configuration and dimensions to be slidably received withinopening 116 formed in first end 111 of cannula or outer penetrator 110h. First end or copper electrode 161 of mandrel 160 may includecorresponding groove 164 with a configuration and dimensionssatisfactory to receive helical coil 192 therein. Groove 164 may beformed with a desired pitch for resulting thread 190 when attached to orbonded with interior portions of cannula 110 h.

For some applications electrode assembly 160 may include enlargedoutside diameter portion or plastic insulator 194 disposed adjacent tofirst end 161. The dimensions and/or configuration of copper electrode161 and plastic insulator 194 may be selected to accommodate installinghelical coil 192 at an optimum location relative to end 116 forretaining biopsy specimens in lumen 118. For example, the dimensions andconfiguration of plastic insulator 194 may be selected to contact theextreme end of outer penetrator or cannula 110 h proximate crowns 115.

Copper electrode 161 of electrode assembly 160 with helical coil 192attached thereto may be inserted into opening 116 in first end 111 h ofcannula 110 h. Electrode assembly 160 may be operable to conductelectricity to copper electrode 161 to accommodate spot welding helicalcoil 192 with adjacent interior portions of longitudinal bore 118 ofcannula 110 h. For some embodiments mandrel 160 may be formed frommaterials compatible with laser welding helical coil 192 with interiorportions of lumen or longitudinal bore 118 of cannula 110 h. Whenattached to interior portions of a cannula or outer penetrator 110 h,helical coil 192 may form a single thread having shoulder 191 extendinggenerally perpendicular to adjacent interior portions of lumen 118. Theresulting dimensions and configuration of helical thread 190 may beselected to optimize retaining a specimen of bone and/or bone marrow onshoulder 191 of thread 190 within lumen 118.

Cannula 110 c of biopsy needle 100 c is shown in FIG. 4C with helicalthread 190 disposed therein. The combination of helical thread 190 withshoulder 191 extending substantially perpendicular to interior portionsof lumen 118 may increase the reliability of biopsy needle 100 c toretain a specimen of bone and/or bone marrow. For some applicationscombining helical thread 190 with cutting surfaces 114 and crowns 115may substantially increase the reliability of obtaining a satisfactorybone specimen when using biopsy needle 100 c with a powered driver inaccordance with teachings of the present disclosure.

Helical thread 190 may be positioned at an optimum location relative toopening 116 in cannula 110 c to begin capture of a bone marrow specimenor cancellous bone core. By inserting biopsy needle 100 c at an optimumfeed corresponding with the pitch of helical thread 190, helical thread190 may be “screwed in” cancellous bone entering opening 116 tosubstantially increase the probability of capturing a satisfactorybiopsy specimen or bone marrow core.

For embodiments such as shown in FIG. 4D cannula or outer penetrator 110d may include first end 111 d having a plurality of exterior cuttingsurfaces 114 d formed thereon and extending therefrom. The length ofcutting surfaces 114 d may be longer than the length of correspondingcutting surfaces 114. Respective crowns 115 d may be formed betweenadjacent cutting surfaces 114 d and 114 g.

For some applications a helical thread having a generally “wedge shaped”cross section similar to an equilateral triangle may be disposed withinthe longitudinal bore or lumen of an outer penetrator or cannulaincorporating teachings of the present disclosure. For example cannula110 d may include helical thread 190 a having a generally wedge shapedcross section corresponding approximately with an equilateral triangle.Helical thread 190 a may be installed within cannula 110 d usingapparatus and procedures as previously described with respect to helicalthread 190.

FIG. 4E shows an example of combining inner penetrator or stylet 120 cwith cannula or outer penetrator 110 c having helical thread 190disposed therein to form biopsy needle set 100 c in accordance withteachings of the present disclosure. Biopsy needle 100 c is shown inFIGS. 3C and 4C without a stylet or trocar. Biopsy needle set 100 c isshown in FIG. 4E with trocar or stylet 120 c disposed in cannula 110 c.Trocar 120 c may include end 121 c with a pair of cutting surfaces 125and a pair of cutting surface 126 as shown in FIG. 3I. Surfaces 125 and126 may cooperate with each other to form a cutting tip on trocar orstylet 120 c similar to a “chisel point” drill bit. The pair of cuttingsurfaces 125 may be offset (relief angle) approximately eight degreesrelative to the pair of cutting surfaces 126. The included angle ofcutting surfaces 125 may be approximately thirty four degrees (34°) plusor minus four degrees (±4°). The included angle of cutting surfaces 126may be approximately sixteen degrees (16°) plus or minus three degrees(±3°).

For some applications end 121 of trocar 120 c may extend from end 111 cof cannula 110 c with respective cutting surfaces 114 of cannula 110 gdisposed adjacent to the end of each cutting surface 126 (short cuttingsurface) opposite from tip 123 of trocar 120 c. See FIG. 4E. As a resultportions of each cutting surface 125 (long cutting surface) of trocar120 c may be disposed within end 111 of cannula 110 c. See FIG. 4E.

Placing portions of cutting surfaces 125 within end 111 of cannula 110 cmay result in more uniform forces being applied to end 101 ofintraosseous device 100 c while penetrating the cortex of an associatedbone using biopsy needle set 100 c and a powered driver in accordancewith teachings of the present disclosure. When the cortex has beenpenetrated, forces applied to end 101 of biopsy needle set 100 c maydecrease sufficiently to indicate that end 101 has now enteredassociated bone marrow. An operator may then withdraw trocar 120 c fromcannula 110 c and position end 111 c of cannula 110 c at a desiredtarget area to perform a bone marrow biopsy.

For some embodiments threads 190 and 190 a may extend approximately0.005 inch from adjacent portions of an associated longitudinal bore orlumen 118. The outside diameter of an associated trocar such as trocar120 c as shown in FIG. 4E may be reduced to accommodate the height ofthread 190 or 190 a. The following test results were obtained duringinsertion of intraosseous devices such as biopsy needle set 100 c shownin FIG. 4E into sawbones material or blocks with three millimeters (3mm) of fifty pound (50#) and forty millimeters (40 mm) of forty pound(40#) material. Test # Motor Torque(g-cm) Time(s) 44 1101 2.23 45 10812.49 46 1071 2.36 47 1081 2.50 48 1030 2.46 49 1070 2.33 Average 10722.40

The distance between the end of cutting surface 126 or trocar 120 c andadjacent cutting surface 114 on cannula 110 c was approximately 0.14inches. End 111 of cannula 110 c had six (6) ground cutting surfaces114. The outside diameter of trocar 120 c was approximately 0.086inches.

Coupler assemblies incorporating teachings of the present disclosure mayfunction as “quick release mechanisms” operable to engage and disengagean IO device from a powered driver disposed within a flexiblecontainment bag or sterile sleeve. Such coupler assemblies may allowrotation of an IO device without damage to the flexible containment bagor sterile sleeve. For some applications the IO device may be anaspiration needle or a biopsy needle. One end of the coupler assemblymay be operable to form a fluid seal or fluid barrier with adjacentportions of the containment bag or sterile sleeve. A coupler assemblyincorporating teachings of the present disclosure may also be describedas a port assembly attached to a containment bag. Such port assembliesmay allow easy engagement or disengagement of a powered driver from anIO device and at the same time allow the powered driver to “power in andpower out” an IO device from an insertion site.

A coupler assembly incorporating teachings of the present disclosure maybe used in “non-sterile” environments and/or medical procedures which donot require the use of a containment bag or sterile sleeve.

FIGS. 5A-5I and 6A-6B show various examples of coupler assemblies orport assemblies incorporating teachings of the present disclosure. FIG.5A-5I are schematic drawings showing various views of powered driver200, coupler assemblies 250, 250 a and 250 b and intraosseous device 100b incorporating various teachings of the present disclosure. Couplerassemblies 250, 250 a and 250 a may each include respective first end251 operable to be releasably engaged with one end of an intraosseousdevice such as, but not limited to, second end 102 of biopsy needle set100 b.

Coupler assembly 250 as shown in FIGS. 5E-5H may include second end 252operable to be releasably engaged with a portion of a drive shaftextending from a powered driver, such as, but not limited to, end 224 ofdrive shaft 222 extending from first end 211 of housing 210 of powereddriver 200. As discussed later, second end 252 of coupler assembly 250may be securely engaged with an opening in a containment bag or sterilesleeve. Second end 252 a of coupler assembly 250 a and second end 252 bof coupler assembly 250 b do not include similar features. As a resultcoupler assemblies 250 a and 250 b may primarily be used in applicationswhich do not require a sterile environment.

Coupler assemblies 250, 250 a and 250 b may have substantially the sameor similar components, functions and features except for second end 252a of coupler assembly 250 a and associated second end 272 a of housingassembly 270 a and second end 250 b of coupler assembly 250 b andassociated second end 272 b of housing assembly 270 b. Therefore,various features of the present disclosure may be described with respectto coupler assembly 250 since both coupler assemblies 250 a and 250 bhave substantially the same characteristics and features except forattachment with a containment bag or sterile sleeve.

Coupler assemblies incorporating various teachings of the presentdisclosure may be placed in a medical procedure tray or kit with one enddown and an opposite end looking up to allow “hands free” releasableengagement with a powered driver or a manual driver. For example,coupler assembly 250 may be disposed in medical procedure tray 20 c withfirst end 251 insert into holders 58 and second end 252 looking up. SeeFIGS. 1C, 1E and 1F. As a result, end 224 of drive shaft 222 extendingfrom powered driver 200 may be inserted into and releasably engaged withsecond end 252 of coupler assembly 250 without requiring an operator oruser (not expressly shown) to physically contact or manipulate anyportion of coupler assembly 250. Various features of associated “handsfree” latching mechanisms will be discussed with respect to FIGS. 5E,5F, 5G and 5H.

As shown in FIGS. 5E and 5F, coupler assembly 250 may include elongatedcore 260 with housing assembly 270 slidably disposed on exteriorportions of elongated core 260. Housing assembly 270 may include firstend 271 and second end 272 which may be generally aligned withrespective first end 261 and respective second end 262 of elongated core260. For some applications, elongated core 260 may have a generallycylindrical configuration defined in first exterior portion 260 a andsecond exterior portion 260 b with various shoulders and/or recessesformed thereon. For some embodiments first exterior portion 260 a mayhave a larger diameter than second exterior portion 260 b.

Coupler assembly 250 a and coupler assembly 250 b may include respectiveelongated cores 260 having similar features and functions as describedwith respect to coupler assembly 250. Coupler assembly 250 a may includehousing assembly 270 a with substantially the same components, functionsand features as described with respect to housing assembly 270 exceptfor second end 272 a of housing assembly 270 a. Coupler assembly 250 bmay include housing assembly 270 b having substantially similarcomponents, functions and features as described with respect to housingassembly 270 except for second end 272 b of housing assembly 270 b.

Housing assembly 270 may be described as having a generally hollow,cylindrical configuration defined in part by first housing segment 280and second housing segment 290. See FIGS. 5E and 5F. The first end ofhousing segment 280 may generally correspond with first end 271 ofhousing assembly 270. The second end of second housing segment 290 maygenerally correspond with second end 272 of housing assembly 270.

First end 291 of second housing segment 290 may be described as having agenerally cylindrical configuration with an outside diameter smallerthan the adjacent inside diameter of second end 282 of first housingsegment 280. First end 291 of second housing segment 290 may slidelongitudinally from a first position (See FIG. 5E) to a second position(See FIG. 5F) within second end 282 of first housing segment 280 torelease one end of a drive shaft engaged with second end 252 of couplerassembly 250.

A biasing mechanism such as coiled spring 274 may be disposed aroundexterior portion 260 a of generally elongated core 260. See for exampleFIGS. 5E and 5F. First end 275 of coiled spring 274 may contact annularshoulder 284 formed on interior portions of first housing segment 280.Second end 276 of coiled spring 274 may contact annular shoulder 278disposed proximate first end 291 of second housing segment 290. Coilspring 274, annular shoulder 284 and annular shoulder 278 may cooperatewith each other to generally maintain first housing segment 280 andsecond housing segment 290 in a first extended position relative to eachother. See FIGS. 5A, 5B, 5C, 5E and 5I. Other biasing mechanisms suchas, but not limited to, leaf springs and bellows (not expressly shown)may also be disposed between annular shoulder 284 and annular shoulder278.

Annular shoulder 278, associated with second end 276 of coiled spring274, may extend radially outward from generally cylindrical ring 277.Generally cylindrical ring 277 may be slidably and rotatably disposed onexterior portion 260 a of elongated core 260. Annular shoulder 279 maybe disposed on interior portions of generally cylindrical ring 277 andmay extend radially inward toward adjacent portions of elongated core260.

Annular shoulder 268 may be formed on exterior portion 260 a ofelongated core 260 intermediate first end 261 and second end 262. Theconfiguration and dimensions of annular shoulder 268 and annularshoulder 279 are selected to be compatible with each other such thatengagement between annular shoulder 279 of generally cylindrical ring277 with annular shoulder 268 of elongated core 260 may limit movementof second housing segment 290 longitudinally in the direction of secondend 262 of elongated core 260.

For some applications a plurality of flexible collets or fingers 477 mayextend from generally cylindrical ring 277 opposite from annularshoulder 278. Respective collet heads 478 may be formed on the end ofeach collet 477 opposite from annular shoulder 278. The dimensions andconfiguration of collet heads 478 may be selected to be received withinrespective slots or openings 297 formed in second housing 290. Duringmanufacture of coupler assembly 250, each collet head 478 may bedisposed within respective slot or opening 297 to securely engagegenerally cylindrical ring 277 and annular shoulder 278 proximate firstend 291 of second housing segment 290. As a result, second housingsegment 290 and annular shoulder 278 may generally move as a single unitrelative to elongated core 260 and first housing segment 280.

During disengagement of an intraosseous device from first end 251 ofcoupler assembly 250, first housing segment 280 may move or slidelongitudinally toward second housing segment 290. In a similar manner,second housing segment 290 may move or slide longitudinally toward firsthousing segment 280 during disengagement of a powered driver from secondend 252 of coupler assembly 250.

Annular shoulder 267 may be formed on exterior portions of elongatedcore 260 proximate first end 261. Annular shoulder 267 may engageportions of first end 271 of housing 270 to limit longitudinal movementof first housing segment 280 during longitudinal movement of secondhousing segment 290 towards first end 261 of elongated core 260 duringdisengagement of a powered driver from second end 252 of couplerassembly 250.

As previously noted, annular shoulder 268 may be formed on exteriorportions of elongated core 260 between first end 261 and second end 262.Engagement between annular shoulder 268 and annular shoulder 279 ofgenerally cylindrical ring 277 may limit movement of second housingsegment 290 toward second end 262 of elongated core 260. Contact betweenspring 274 and annular shoulder 278 and annular shoulder 284 of firsthousing segment 280 may limit the longitudinal movement of first housingsegment 280 in the direction of second end 262 of elongated core 260during disengagement of an intraosseous device from first end 251 ofcoupler assembly 250.

Generally cylindrical ring 277 and attached annular shoulder 279 mayslide longitudinally on exterior portions of annular core 260 betweenannual shoulder 268 and annular shoulder 267. First housing segment 280may move longitudinally toward second end 262 of elongated core 260 torelease one end of intraosseous device from engagement with first end251 of coupler assembly 250. In a similar manner, second housing segment290 may move longitudinally toward first end 261 of elongated core 260to release one end of a drive shaft extending from a powered driverengaged with second end 252 of coupler assembly 250.

A wide variety of latches and latch mechanisms may be satisfactorilyused to releasably engage one end of an intraosseous device within afirst end of a coupler assembly incorporating teachings of the presentdisclosure. In a similar manner, a wide variety of latches and latchmechanisms may be satisfactorily used to releasably engage one end of adrive shaft extending from a powered driver or manual driver within asecond end of the coupler assembly incorporating teachings of thepresent disclosure.

For embodiments represented by coupler assemblies 250, 250 a and 250 b,first latch 410 may be disposed on exterior portions of elongated core260 proximate receptacle 263 adjacent to first end 261 to releasablyengage one end of an IO device such as second end 102 of biopsy needleset 100 b within receptacle 263 of coupler assembly 250, 250 a and/or250 b. Second latch mechanism 420 may be disposed on exterior portionsof elongated core 260 proximate receptacle 264 adjacent to second end262 to releasably engage one end of a drive shaft with second end 252 ofcoupler assembly 250. See FIGS. 5C, 5E and 5I.

Second latch 420 may be used to releasably engage one portion of a driveshaft such as end 224 of drive shaft 222 extending from powered driver200 within second end 252 of coupler assembly 250, 250 a and/or 250 b.Latch 410 may releasably engage an intraosseous device with first end251 of coupler assembly 250 substantially the same latch 420 mayreleasably engage a powered driver with second end 252 of couplerassembly 250.

For some applications, latches 410 and 420 may have similarconfigurations such as a general “omega” shape. See latch 420 in FIGS.5G and 5H. However, latch 410 may have larger dimensions correspondinggenerally with exterior portion 260 a of elongated core 260. Latch 420may have smaller dimensions corresponding generally with exteriorportion 260 b of elongated core 260. Various features of the presentdisclosure may be described with respect to latch mechanism 420 as shownin FIGS. 5G and 5H along with adjacent portions of second housingsegment 290 and exterior portion 260 b of elongated core 260.

Respective detents 421 and 422 may be formed on opposite ends ofgenerally omega shaped latch 420. See FIGS. 5D, 5G and 5H. In a similarmanner, respective detents (not expressly shown) may be formed on theends of generally omega shaped latch 410. The configuration anddimensions of detents 421 and 422 may be compatible with placing eachdetent 421 and 422 in respective slot or opening 431 and 432 extendingbetween exterior portion 260 b of elongated core 260 to interiorportions of receptacle 264 disposed proximate second end 252 of couplerassembly 250.

Latch 420 may have a first position such as shown in FIGS. 5D and 5G inwhich portions of detents 421 and 422 may extend through respectiveslots 431 and 432. The dimensions and configuration of detent 421 and422 may be operable to be securely engaged with annular groove 402formed in end 224 of powered driver 200. In a similar manner, respectivedetents on associated latch 410 may be releasably engaged with annulargroove 401 disposed in second end 102 of biopsy needle 100 b.

For some applications, a plurality of tapered surfaces 403 may be formedon exterior portions of hub 140 a proximate first end 142 (See FIG. 5C)to radially expand detent mechanisms associated with omega shaped latch410 radially outward while inserting second end 102 of biopsy needle 100b into first end 251 of coupler assembly 250, 250 a or 250 b. The detentmechanism may “snap” into annular groove 401 when aligned therewith. Ina similar manner, a plurality of tapered surfaces 228 may be formed onexterior portions of end 224 of drive shaft 222 extending from powereddriver 200 to radially expand detent mechanisms 421 and 422 radiallyoutward during the insertion of end 224 of powered driver 200 intosecond end 252 of coupler assembly 250. Detent mechanisms 421 and 422will “snap” into annular groove 402 when aligned therewith. See FIG. 5F.

Engagement between detent mechanisms associated with latch 410 withannular groove 401 of hub assembly 130 a will generally retain secondend 102 of biopsy needle 100 b securely engaged with first end 251 ofcoupler assembly 250. This engagement may allow powered driver 200 torotate or spin cannula or biopsy needle 110 b while withdrawing cannulaor biopsy needle 11 b from an insertion site. In a similar manner,engagement between detent mechanisms 421 and 422 of omega shaped latch420 and annular groove 402 of end 224 of powered driver 200 willgenerally retain second end 252 of coupler assembly 250 engaged withpowered driver 100 during withdrawal of cannula 110 b from an insertionsite.

Biopsy needle set 100 b may be released from first end 251 of couplerassembly 250 by sliding first housing segment 280 longitudinally towardsecond end 262 of elongated core 260. Such movement of first housingsegment 280 will result in interior tapered surface 286 contactingexterior portions of omega shaped latch 410 and compressing omega shapedlatch 410 to radially expand associated detent mechanisms (not expresslyshown) from engagement with annular groove 401 of hub assembly 130 a. Asa result, biopsy needle set 100 b may be easily withdrawn from first end251 of coupler assembly 250.

In a similar manner, longitudinal movement of second housing segment 290toward first end 251 of coupler assembly 250 will result in interiortapered surface 296 contacting exterior portions of omega shaped latch420 to compress generally omega shaped latch 420 and withdraw or retractdetent mechanisms 421 and 422 from engagement with annular groove 402 ofend 224. See FIGS. 5F and 5H. As a result, powered driver 200 and secondend 222 of coupler assembly 250 may be easily disconnected from eachother.

Coupler assemblies 250 and 250 a may have substantially the same overallconfiguration and dimensions including respective flange 254 extendingradially from second end 252 and 252 a. Flange 254 may be generallydescribed as having an enlarged funnel shaped or bell shapedconfiguration. The dimensions and configuration of flange 254 may beselected to be compatible with end 211 of powered driver 200. Couplerassembly 250 b does not have a respective flange 254. See FIG. 5I.Second end 272 b of housing assembly 270 b may terminate proximate firstend 262 of associated elongated core 260 and associated second end 252 bof coupler assembly 250 b.

As previously noted, coupler assembly 250 may be securely engaged withan opening formed in a containment bag or sterile sleeve in accordancewith teachings of the present disclosure. For embodiments such as shownin FIGS. 5E and 5F second end 272 of housing 270 of coupler assembly 250may include annular ring 370 operable to be securely engaged withadjacent portions of flange 254. The outside diameter of annular ring370 may generally correspond with the outside diameter of adjacentportions of flange 254. The inside diameter of annular ring 370 may alsogenerally correspond with the inside diameter of adjacent portions offlange 254.

For some embodiments a plurality of posts 372 and generally V shapedgrooves 374 may be alternatingly disposed on the extreme end of flange254. Annular ring 370 may include a plurality of holes 371 sized toreceived respective posts 372 therein. Annular ring 370 may also includea plurality of generally V shaped projections 376 sized to be receivedwithin respective generally V shaped grooves 374 formed in adjacentportions of flange 254.

For embodiments such as shown in FIGS. 1C, 1E, 1F, 7A and 7B portions ofcontainment bag 170 adjacent to first opening 171 may be disposedbetween annular ring 370 and adjacent portions of flange 254. Forexample, post 372 may be inserted through respective holes (notexpressly shown) in containment bag 170 adjacent to the perimeter ofopening 171. Holes 371 in annular ring 370 may be aligned withrespective posts 372. Other portions of bag 170 adjacent to opening 171may be trapped between respective V shaped projections 376 and V shapedgrooves 374. Various welding techniques including, but not limited to,laser welding may be applied to posts 372 to bond annular ring 370 withadjacent portions of flange 354. As a result, the perimeter ofcontainment bag 170 adjacent to first opening 171 may be securelyengaged with second end 252 of coupler assembly 250. See FIGS. 7A and7B.

FIGS. 6A and 6B are schematic drawings showing powered driver 200 a,coupler assembly 250 b and biopsy needle set 100 b incorporating variousteachings of the present disclosure. Coupler assembly 250 b may includefirst end 251 operable to be releasably engaged with second end 102 ofintraosseous device 100 b. Coupler assembly 250 b may also includesecond end 252 operable to be releasably engaged with end 224 a of driveshaft 222 a extending from first end 211 of powered driver 200 a.

As shown in FIG. 6B, second end 102 of biopsy needle set 100 b may bereleasably disposed within first end 251 of coupler assembly 250 b. End224 a of drive shaft 222 a extending from end 211 of powered driver 220a may be releasably engaged with second end 252 b of coupler assembly250. For embodiments represented by coupler assembly 250 b, second end252 of coupler assembly 250 b may include tapered receptacle 264 bhaving a configuration and dimensions corresponding generally withtapered end 224 a of powered driver 220 a.

Coupler assembly 250 b may include generally elongated core 260 b withhousing assembly 270 b slidably disposed on exterior portions ofelongated core 260 b adjacent to first end 251. Second end 272 ofhousing assembly 270 b may be disposed adjacent to shoulder 278 b formedon exterior portions of elongated core 260 b. Coiled spring 274 may bedisposed on exterior portions of elongated core 260 b between shoulder284 b of housing 270 b and shoulder 278 b of elongated core 260 b.Coiled spring 274 may bias housing assembly 270 b to a first positionwith first end 271 of housing 270 b generally aligned with first end 261of elongated core 260 b. See FIG. 6B.

For some applications, coupler assembly 250 b may include latchmechanism 430 disposed proximate second end 252 of coupler assembly 250b. Latch mechanism 430 may be generally described as having an “L”shaped configuration defined in part by first segment 431 extendinggenerally parallel with elongated core 260 b and second segment 432extending generally perpendicular with respect to elongated core 260 bproximate second end 262. Second segment 432 may include an enlargedopening 434 sized to allow inserting end 224 a of powered driver 200 ainto receptacle 264 b. Segment 432 of latch mechanism 430 may alsoinclude detent mechanism 436 sized to be releasably engaged withinannular groove 402 proximate end 224 a of powered driver 200 a. See FIG.6B.

During attachment of coupler assembly 250 b with end 224 a of powereddriver 200, first segment 431 may be manually depressed to compressspring 438 and to move detent mechanism 436 to allow full access toreceptacle 264 b disposed in second end 252 b of coupler assembly 250 b.End 224 a of powered driver 200 a may then be inserted through opening434 into receptacle 264 b. First segment 431 of latch mechanism 430 maynext be released, which will allow detent mechanism 436 to be securelyengaged within annular groove 402 of end 224 a of powered driver 200 a.As a result, coupler assembly 250 b will remain securely engaged withpowered driver 200 a until first segment 431 is again depressed todisengage detent mechanism 436 from annular groove 402.

Latch mechanism 410 b may be disposed on exterior portions of elongatedcore 260 b proximate first end 261. Latch mechanism 410 b may beoperable to be releasably engaged with and disengaged from annular 401in an associated intraosseous device such as annual groove 401 formed insecond end 102 of biopsy needle 100 b. See FIG. 6B. Housing 270 b mayslide longitudinally from first end 271 toward second end 252 of couplerassembly 250 b to release engagement between latch mechanism 410 b andannular groove 401 formed in second end 102 of biopsy needle set 100 b.

For some embodiments, annular ring 440 may be disposed on exteriorportions of coupler assembly 250 b proximate second end 252. Annularring 440 is shown in FIG. 6B. Annular ring 440 is not shown in FIG. 6A.Groove 442 may be formed in exterior portions of annular ring 440 toaccommodate securely engaging the perimeter of a first opening in acontainment bag therewith. The dimensions and configuration of annularring 440 may be selected to allow rotation of coupler assembly 250 bwithin annular ring 440. As a result a containment bag attached withannular ring 440 will generally not be damaged by rotation of couplerassembly 250 b.

FIGS. 7A and 7B are schematic drawings showing one example of acontainment bag or sterile sleeve engage with a coupler assembly inaccordance with teachings of the present disclosure. FIG. 7A showspowered driver 200 prior to placing within containment bag 170.Containment bag 170 may be generally described as having first opening171 and second opening 172. For some applications, containment bag 170may be formed from generally clear, flexible plastic-like material.

First opening 171 may be sized to securely engage second end 252 ofcoupler assembly 250 therewith. For embodiments represented by couplerassembly 250, annular ring 370 may be used to securely engage portionsof containment bag 170 proximate first opening 171 with second end 252of coupler assembly 250. See FIGS. 5E and 5F. A fluid barrier may beformed between portions of containment bag 170 adjacent to first opening171 and adjacent portions of second end 252 of coupler assembly 250.

The dimensions and configuration of second opening 172 of containmentbag 170 are preferably selected to allow inserting powered driver 200therethrough. Various closure mechanisms may be satisfactorily used toclose second opening 172 after end 224 of powered driver 200 has beenengaged with second end 252 of coupler assembly 250. For someapplications, flap 174 may be folded over second opening 172. Varioustypes of self sealing adhesive materials may be satisfactorily used toreleasably engage portions of flap 174 with adjacent portions ofcontainment bag 170. The present disclosure is not limited to usingflaps and adhesive materials to close an opening in a containment bag.

FIG. 8 is a schematic drawing showing an exploded isometric view ofcoupler assembly 250 c and hub assembly 130 c with intraosseous device100 d extending therefrom. First end 101 of intraosseous device 100 dmay be operable to be inserted into a bone and associated bone marrow.Intraosseous device 100 d may include cannula 110 c extending from hub140 c. Inner penetrator or trocar 120 may extend from first end 151 ofhub 150 c. First end 151 of hub 150 c may be sized to be releasablyinserted into second end 142 of hub 140 c. First end 251 of couplerassembly 250 c may be releasably inserted into second end 152 of hub 150c. For embodiments such as shown in FIG. 8, first end 251 of couplerassembly 250 c, second end 152 of hub 150 c, first end 151 of hub 150 cand second end 142 of hub 140 c may be described as having generallyrectangular configurations.

Latch assembly 256 may be satisfactorily used to releasably engage oneend of a drive shaft within second end 252 d of coupler assembly 250 c.For other applications, latch assembly 256 may include detent 436operable to engage annular groove 402 in end 224 a powered driver 200 a.For other applications manual drive shaft 99 extending from manualdriver 98 may also be releasably engaged with second end 152 of hub 150.

Various types of ejectors, ejector rods, funnels and/or ejector funnelsmay also be used with a biopsy needle, biopsy needle sets and/or otherintraosseous devices incorporating teachings of the present disclosure.For some applications, funnels formed in accordance with teachings ofthe present disclosure may include a respective first opening formed ata first end and a respective second opening at a second end of thefunnel. The first opening and the second opening may have differentinside diameters.

For example, the first opening may be sized to accommodate inserting abiopsy needle therein while the second opening may have a reduced insidediameter which prevents inserting the biopsy needle therein. The secondopening may be sized to only accommodate one end of an associatedejector rod. For some applications, a longitudinal passageway may extendbetween the first end and the second end of the funnel. Tapered surfacesmay be formed within the longitudinal passageway adjacent to the firstend. The tapered surfaces may function as a “one way” connector suchthat when a biopsy needle is inserted therein, the funnel will besecurely engaged with the first end of the biopsy needle. The funnel maythen function as a sharps protector for the first end of the biopsyneedle.

FIGS. 9A, 9B and 9C show some examples of apparatus and methods whichmay be used to remove a biopsy specimen from a generally hollow cannulaor biopsy needle after inserting a first end of the generally hollowcannula or biopsy needle into a bone and/or associated bone marrow.Funnel 80 as shown in FIG. 9A may include first end 81 and second end 82with a generally hollow, cylindrical portion 83 extending therebetween.Generally hollow, cylindrical portion 83 may include a longitudinalpassageway (not expressly shown) sized to accommodate one end of anassociated intraosseous device and first end 91 of ejector 90. For someapplications ejector 90 may also be referred to as an “ejector rod”.

The length of ejector 90 may be selected to be greater than the lengthof a lumen in an associated biopsy needle. Handle or hub 96 may bedisposed on second end 92 of ejector 90. The dimensions andconfiguration of first end 91 of ejector rod 90 may be selected to becompatible with inserting first end 91 through an opening in the firstend of an associated biopsy needle.

Funnel 80 a as shown in FIGS. 9B and 9C represents an alternativeembodiment of the present disclosure. First end 81 a of funnel 80 a mayhave a configuration and dimensions compatible with inserting the firstend of an intraosseous device such as first end 101 of biopsy needle 100c therein. Second end 82 a may have a modified configuration as comparedwith second end 82 of previously described funnel 80. The dimensions andconfiguration of second end 82 a may be selected to be compatible withplacing funnel 80 a in a medical procedure tray with first end 81 aoriented generally upward to allow inserting one end of an intraosseousdevice therein. See FIGS. 1C and 1D.

For embodiments such as shown in FIGS. 9B and 9C funnel 80 a may includefirst end 81 a sized to be securely engaged with one end of anintraosseous device such as first end 101 of biopsy needle 100 c. Funnel80 a may include second end 82 a sized to slidably receive first end 91of ejector 90 therein. Longitudinal passageway 84 may be disposed infunnel 80 a extending between first end 81 a and second end 82 a.

For some applications first tapered opening 87 may be formed proximatefirst end 81 a. Second tapered opening 88 may be formed proximate secondend 82 a. First tapered opening 87 may be sized to allow inserting end101 of biopsy needle 100 c through and into first segment 84 a oflongitudinal passageway 84. Second tapered opening 88 may be sized toonly allow inserting end 91 of ejector 90 therethrough and into reduceddiameter portion 84 b of longitudinal passageway 84. Reduced diameterportion 84 b may be smaller than the outside diameter of biopsy needle100 c or other intraosseous devices.

For some applications longitudinal passageway 84 may include taperedinside diameter portion 84 a disposed adjacent to and extending fromfirst opening 87. The tapered inside diameter portion 84 a may limitmovement of the first end 101 of biopsy needle 100 c or otherintraosseous device therethrough. The configuration and dimensionsassociated with tapered inside diameter portion 84 a may be described asa “sticking taper” which will result in securely engaging funnel 80 awith the first end of an intraosseous device inserted therein. As aresult of providing a “sticking taper” within longitudinal passageway84, funnel 80 a may then be withdrawn from a respective holder in amedical procedure kit to allow inserting injector rod 80 through secondend 82 a. Funnel 80 a also may serve as a sharps protector since it isnow securely engaged with the first end of the associated intraosseousdevice.

One of the benefits of the present disclosure may include the ability tosecurely engage one end of an intraosseous device with a funnel withoutrequiring an operator to hold the funnel or the intraosseous deviceduring such engagement. A powered driver and coupler assemblyincorporating teachings of the present disclosure may be satisfactorilyused to insert the one end of the intraosseous device into the funnel.The coupler assembly may then be releasably disengaged from an oppositeend of the intraosseous device.

Benefits of the present disclosure may include reducing physical demandsand mental stress on operators and patients by increasing speed andcontrol of aspiration needle insertion during cancellous bone and bonemarrow harvesting procedures. A bone marrow aspiration systemincorporating teachings of the present disclosure may include a batterypowered driver, a coupler assembly, a containment bag and an aspirationneedle set. The powered driver, while disposed in a sterile containmentbag, may rotate the coupler assembly and attached aspiration needle setto penetrate the cortex of a bone and associated cancellous bone to adesired depth to extract bone marrow. The driver and connector assemblymay then be separated from the aspiration needle set. A hub assemblyattached to one end of the aspiration needle set may be manipulated toleave an aspiration needle or cannula securely seated in the bone. Astandard Luer lock fitting (part of the hub assembly) may be attachedwith a standard syringe or flexible tubing extending from a bone marrowaspiration system.

FIG. 10 is a schematic drawing showing an aspiration needle disposed ina portion of a hip bone often referred to as the ilium. One of thepenetration sites or insertion sites frequently used to obtain bonemarrow from a hip bone may be the posterior iliac crest. Anotherinsertion site may be the anterior iliac crest (not expressly shown).Bone marrow may also be aspirated from the tibia (leg bone) and sternum(chest).

Hip bone 300 as shown in FIG. 10 may include three segments—the ilium,the ischium and the pubis. These segments are generally distinct fromeach other in young patients but are generally fused together in adults.Skin and soft tissue 302 generally cover insertion sites in crest 304 ofthe ilium.

All bones generally include a tough, hard to penetrate layer of cortex.Crest 304 OF HIP BONE 300 typically includes cortex layer 306. FIG. 10shows enlarged skin and soft tissue layer 302 and cortex layer 306 forillustration purposes only. A typical thickness for skin and soft tissuelayer 302 may be seven to eight millimeters (7 mm to 8 mm). A typicalthickness for cortex layer 306 may be approximately two millimeters (2mm).

As previously discussed intraosseous (IO) device or aspiration needleset 100 a may be inserted in the crest of the ilium or any otherinsertion site with minimum trauma to obtain bone and/or bone marrowsamples in accordance with teachings of the present disclosure.

FIG. 10 shows one example of a system for aspirating bone marrow from abone using apparatus and methods incorporating teachings of the presentdisclosure. Samples of bone and/or bone marrow may be obtained from anysuitable bone including, but not limited to, tibia (leg bone), ilium(pelvis) or sternum (chest) using apparatus and methods incorporatingteachings of the present disclosure. FIG. 10 shows cannula or aspirationneedle 110 a inserted into a target area in a patient's ilium.

For one embodiment, system 310 may include a source of vacuum or lowpressure 312, collection container 314, vacuum tubing 316 and collectiontubing 318. Source of vacuum 312 may be a pump such as shown in FIG. 10or may be a portion of a hospital or operating suite low pressure vacuumsystem (not expressly shown). Vacuum tubing 316 may extend betweenvacuum source 312 and collection container 314. Various types of tubingmay be satisfactorily used to form vacuum tubing 316 and/or collectiontubing 318. The length of vacuum tubing 316 and/or collection tubing 318may be varied depending upon each facility in which system 310 is used.

Collection tubing 318 may extend between collection container 314 andintraosseous (IO) connector assembly 320. Various types of connectionsand connector assemblies including, but not limited to, IO connectorassembly 320 may be used to communicate fluids between an IO device suchas aspiration needle 110 a and collection tubing 318.

IO connector assembly 320 may include coupling or tubing connector 322operable to be releasably engaged with one end of collection tubing 318opposite from container 314. Various types of couplings associated withIV tubing may be satisfactorily used. Relatively short, flexible tubing324 may extend between tubing connector 322 and right angle connector326. For some applications, flow control device or tubing stop 328 maybe attached to flexible tubing 324 between coupling 322 and right angleconnector 326.

Flow control device 328 may have a first, open position as shown in FIG.10 and a second, closed position (not expressly shown). Flow controldevice 328 may be used to prevent fluid flow from IO device 110 a duringengagement and disengagement with collection tubing 318 or any otherapparatus such as IV tubing (not expressly shown) which may be attachedto IO connector assembly 320.

Flow control device 328 may be formed from relatively flexible materialwhich allows compressing or squeezing flow control device 328 to engagenotch or hook 330 with end 332. Compression of flow control device 328will preferably result in clamps 334 and 336 compressing or closing offfluid flow through the lumen of flexible tubing 324. Engagement of notch330 with end 336 will hold flow control device 328 in its second, closedposition.

Right angle connector 326 may be engaged with one end of flexible tubing324 opposite from coupling 322. Right angle connector 326 allowsflexible tubing 324 to be connected to aspiration needle 110 a at anangle that will generally not kink or pinch off the lumen of tubing 324.Right angle connector 326 may also include Luer connector 340 operableto be releasably connected with second end 142 of first hub 140 a. Atapered portion (not expressly shown) of Luer connector 340 may beinserted into tapered opening 144 formed in second end 142 of first hub140 a.

Lock nut 342 may be disposed on exterior portions of right angleconnector 326 adjacent to Luer connector 340. Flange 344 may also beformed on the exterior of right angle connector 326 adjacent Luerconnector 340. Lock nut 342 may be both rotatably and slidably disposedon the exterior portion of right angle connector 326 adjacent to Luerconnector 340 with flange 344 disposed between lock nut 342 and Luerconnector 340. Threads 346 formed on interior portions of lock nut 342may be used to releasably engage right angle connector 326 with threads148 formed adjacent to second end 142 of first hub 140 a.

After aspirating a desired bone marrow sample from the target area shownin FIG. 10, IO connector assembly 320 may be disconnected from secondend 142 of first hub 140 a. Second hub 150 a (with or without a trocarattached thereto) may be reconnected with second end 142 of first hub140 a. Powered driver 200 and coupler assembly 250 may be reconnected tohub assembly 130 a to remove (power out) aspiration needle 110 a orinsert aspiration needle 110 a to another target area in hip bone 300.

Although the present disclosure and its advantages have been describedin detail, it should be understood that various changes, substitutionsand alternations can be made herein without departing from the spiritand scope of the invention as defined by the following claims.

1. Apparatus operable to obtain a biopsy sample of a bone and/orassociated bone marrow comprising; a powered driver having a drive shaftwith a portion of the drive shaft extending from one end of the powereddriver; a biopsy needle set having a first end operable to penetrate thebone and associated bone marrow; a coupler assembly having a first endoperable to be releasably engaged with a second end of the biopsy needleset; the coupler assembly having a second end operable to be releasablyengaged with the portion of the drive shaft extending from the one endof the powered driver; the biopsy needle set including a cannula havinga first end and a second end with a longitudinal bore extending throughthe cannula from the first end to the second end; an opening formed inthe first end of the cannula; a plurality of cutting surface disposed onthe first end of the cannula proximate the opening; and the cuttingsurfaces operable to penetrate bone and associated bone marrow.
 2. Theapparatus of claim 1 further comprising a single thread disposed oninterior portions of the longitudinal bore of the cannula proximate theopening in the first end of the cannula.
 3. The apparatus of claim 2wherein the single thread further comprises: a generally helical coilhaving a wedge shaped cross section defined in part by a base portionwider than other portions of the helical coil; and the base portion ofthe wedge shaped cross section bonded with adjacent interior portions ofthe longitudinal bore of the cannula.
 4. The apparatus of claim 3further comprising: one side of the cross section extending generallyperpendicular from the base portion; and the base portion of the helicalcoil welded to the adjacent interior portions of the longitudinal boreof the cannula.
 5. The apparatus of claim 1 further comprising: acontainment bag having a closable opening sized to allow placing thepowered driver within the containment bag; a first end of the couplerassembly disposed within the containment bag; the first end of thecoupler assembly operable to be releasably engaged with the portion ofthe drive shaft extending from the powered driver; a second end of thecoupler assembly disposed exterior to the containment bag; and thesecond end of the coupler assembly operable to be releasably engagedwith the biopsy needle set.
 6. The apparatus of claim 5 furthercomprising a fluid barrier formed between adjacent portions of thecontainment bag and exterior portions of the coupler assembly.
 7. Theapparatus of claim 1 further comprising: a powered driver having a gearassembly; an associated hollow biopsy needle with at least one internalthread having a pitch; and the gear assembly having a speed reductionratio synchronized with rotational speed of the motor and the pitch ofthe at least one internal thread for optimum performance of the biopsyneedle in obtaining a bone marrow sample.
 8. The apparatus of claim 1wherein the powered driver further comprises: a gear assembly disposedbetween and rotatably engaged with the motor and the drive shaft; andthe gear assembly having a speed reduction ratio selected to optimizeinsertion of a biopsy needle into a target area.
 9. The apparatus ofclaim 8 further comprising the gear assembly operable to rotate thedrive shaft, coupler assembly and biopsy needle attached thereto atoptimum revolutions per minutes (RPM) to capture a bone marrow biopsyspecimen.
 10. A method of forming a generally hollow biopsy needleoperable to be used with a powered driver to obtain a sample of bonemarrow from a selected target area comprising: forming the biopsy needlewith a generally elongated hollow bore extending longitudinally from afirst end to a second end thereof; forming a mandrel having a first endoperable to be inserted into the first end of the biopsy needle; placinga generally helical coil on an exterior portion of the mandrel adjacentto the first end of the mandrel; positioning the first end of themandrel at an optimum location within the generally elongated hollowbone of the biopsy needle; and transferring the helical coil from themandrel to an inside diameter of the biopsy needle adjacent to the firstend thereof.
 11. The method of claim 10 further comprising: forming themandrel from material operable to function as an electrode; and applyingelectrical powered to the mandrel to weld the helical coil with interiorportions of the longitudinal bone.
 12. The method of claim 10 furthercomprising: forming a helical groove in exterior portions of the mandreladjacent to the first end of the mandrel; and installing the helicalcoil within the helical groove.
 13. The method of claim 10 furthercomprising: forming an enlarged outside diameter portion on the mandrelspaced from the first end of the mandrel; forming the enlarged outsidediameter portion at a distance from the first end of the mandrel to theenlarged outside diameter portion selected to correspond with a desiredlocation for installing the helical coil within the biopsy needle; andcontacting the first end of the generally hollow biopsy needle with theenlarged outside diameter portion of the mandrel.
 14. The method ofclaim 10 further comprising forming a plurality of sharp cuttingsurfaces immediately adjacent to exterior portions of the first end ofthe biopsy needle.
 15. An biopsy needle operable to be rotatablyinserted into a bone and associated bone marrow comprising: a first endoperable to penetrate the bone and associated bone marrow; a generallyhollow bore disposed in and extending from a respective opening in thefirst end to a respective opening in a second end of the biopsy needle;the first end of the biopsy needle having a plurality of crowns disposedon exterior portions thereof adjacent to the respective opening in thefirst end; the second end of the biopsy needle attached to and extendingfrom a first end of a hub; a passageway disposed in and extending from asecond end of the hub toward the first end of the hub; and thepassageway in the hub generally aligned with and communicating with thegenerally hollow bore disposed in the biopsy needle.
 16. The biopsyneedle of claim 15 further comprising: six crowns with each crown havingapproximately the same configuration and dimensions disposed on exteriorportions of the hollow cannula adjacent to the first end; and each crowndefined in part by a narrow pointed tip with respective generally sharpunshaped cutting surfaces disposed between adjacent tips.
 17. The biopsyneedle of claim 15 further comprising a single helical groove disposedin interior portions of the generally hollow bore proximate therespective opening in the first end of the biopsy needle.
 18. The biopsyneedle of claim 15 further comprising a generally helical threaddisposed on interior portions of the generally hollow bore proximate therespective opening in the first end of the biopsy needle.
 19. The biopsyneedle of claim 18 wherein the single thread further comprises: agenerally helical thread having a cross section corresponding generallywith a right triangle; a base portion of the helical thread wider thanother portions of the helical thread; and the base portion of thehelical thread bonded with adjacent interior portions of the elongatedbore of the biopsy needle.
 20. The biopsy needle of claim 15 furthercomprising: a helical coil formed at least in part from a metal alloy;and a base portion of the helical coil welded to the adjacent interiorportions of the elongated bore of the biopsy needle.
 21. The biopsyneedle of claim 15 further comprising at least one internal thread witha pitch corresponding with the pitch of a conventional wood screw.
 22. Amethod of obtaining a bone marrow specimen from a bone marrow cavitydisposed within a bone comprising: releasably engaging one end of adrive shaft extending from with a powered driver with one end of acoupler assembly; releasably engaging one end of a biopsy needle to anopposite end of the coupler assembly; rotating the powered driver andcoupler assembly in one direction at a relatively constant speed whileinserting another end of the biopsy needle through the bone and intoadjacent bone marrow; and releasing the biopsy needle from the couplerassembly.
 23. The method of claim 22 further comprising rotating thebiopsy needle at approximately two hundred and fifty to three hundred(250-300) revolutions per minute.
 24. A biopsy needle operable to berotatably inserted into a bone and associated bone marrow comprising: afirst end operable to penetrate the bone and associated bone marrow; alumen extending from a respective opening in the first end to arespective opening in a second end of the biopsy needle; a plurality ofcutting surfaces disposed on exterior portions of the first end of thebiopsy needle adjacent to the respective opening in the first end; thebiopsy needle having a generally uniform outside diameter extending fromthe second end of the biopsy needle to a location spaced from the firstend of the biopsy needle; exterior portions of the biopsy needle havinga generally tapered outside diameter extending from the generallyuniform outside diameter portion to the plurality of cutting surfacesdisposed on the first end; a hub with a passageway extending from asecond end of the hub toward a first end of the hub; the biopsy needleextending from the first end of the hub with the second end of biopsyneedle disposed within the passageway of the hub; and the passageway inthe hub generally aligned with the lumen of the biopsy needle. 25.Apparatus operable to remove a biopsy specimen from a generally hollowcannula after inserting a first end of the generally hollow cannula intoa bone and associated bone marrow comprising: an ejector having agenerally elongated configuration defined in part by a first end of theejector operable to be inserted into an opening proximate the first endof the generally hollow cannula; exterior portions of the ejector sizedto be slidably received within a longitudinal bore of the generallyhollow cannula; a funnel having a first end sized to be engaged with thefirst end of the generally hollow cannula; the funnel having a secondend sized to slidably receive the first end of ejector therein; alongitudinal passageway disposed in the funnel extending between thefirst end of the funnel and the second end of the funnel; and thelongitudinal passageway of the funnel operable to direct movement of thefirst end of the ejector from the second end of funnel into the openingproximate the first end of the generally hollow cannula.
 26. Theapparatus of claim 25 further comprising the funnel operable to beengaged with the one end of the generally hollow cannula to function asa sharps protector with respect to one or more cutting surfaces disposedon the one end of the generally hollow cannula.
 27. The apparatus ofclaim 25 further comprising the ejector having a length greater than alength of the longitudinal bore of the generally hollow cannula.
 28. Afunnel operable for use in removing a biopsy sample from a lumen in abiopsy needle, the funnel comprising: a first end and a second end witha longitudinal passageway extending between the first end and the secondend; a first tapered opening disposed proximate the first end of thefunnel; the tapered opening sized to allow inserting one end of thebiopsy needle therein; the longitudinal passageway having a reducedinside diameter portion disposed adjacent to the second end of thefunnel; the reduced inside diameter portion sized to limit movement ofthe one end of the biopsy needle through the longitudinal passagewayfrom the first end toward the second end of the funnel; and the secondend of the funnel having a second tapered opening sized to allowinsertion of an ejector rod through the second tapered opening and intothe reduced inside diameter portion of the longitudinal passageway. 29.The funnel of claim 28 further comprising an interior portion of thelongitudinal passageway adjacent to the first end having a taperedsurface sized to engage the funnel with the one end of the biopsy needleafter the one end of the biopsy needle has been inserted therein wherebythe funnel provides sharps protection for the one end of the biopsyneedle.